We have recently learned more information on the Persona Knee Recall. A Persona Knee Recall Notice was sent by Zimmer to medical facilities throughout the United States that implanted the Persona Knee Implant System, and specifically the Persona Trabecular Metal™ Tibial Plate (all sizes). Since the recall effects approximately 11,658 U.S. citizens, we wanted to alert you to this important information as quickly as possible.
To: Risk Managers and Surgeons
Subject: URGENT MEDICAL DEVICE RECALL
Affected Product: Persona Trabecular Metal™ Tibial Plate, all sizes (see Attachment 1 for a complete list)
Zimmer is initiating a voluntary recall of the Persona Trabecular Metal™ Tibial Plate as the current complaint rate (0.61%) for radiolucent lines and loosening is higher than Zimmer’s expectations and experience based on Zimmer’s similar devices. Affected product has been distributed from November 29, 2012 until January 23, 2015.
Out of the complaints received, 36% identified symptomatic radiolucent lines or were revised for loosening, 28% identified asymptomatic radiolucencies, 8% subsided, and 28% were inconclusive. Aseptic loosening of cementless tibial implant components is one of the most prevalent causes for revision in total knee arthroplasty and a number of factors may contribute to the loosening failure mode, including patient characteristics, rehabilitation protocol and compliance, surgical technique, and product features.
Persona Trabecular Metal™ Tibial Plate, all sizes
|Immediate health consequences (injuries or illness) that may result from use of or exposure to the device issue.||Most Probable||Worst Case|
|None||Implant does not have appropriate initial fixation causing patient pain|
|Long range health consequences (injuries or illness) that may result from use of or exposure to the device issue.||Most Probable||Worst Case|
|None||Implant never achieves appropriate biological fixation, leading to revision surgery|
1. Review the notification and ensure affected personnel are aware of the contents.
2. Assist your Zimmer sales representative with the quarantine of any affected product.
3. Your Zimmer sales representative will remove the recalled product from your facility.
This voluntary recall will be reported to the U.S. Food and Drug Administration.
MedWatch Reporting: Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
Under 21 CFR Part 803, manufacturers are also required to report any serious injuries where a device has contributed to or may have contributed to the event. Please keep Zimmer informed of any adverse events associated with this device or any other Zimmer product. Adverse events may be reported to Zimmer at email@example.com.
|ATTACHMENT 1 Part Number||Description|
|42-5300-064-01||Persona Two-Peg Trabecular Metal™ Tibia, TM Size C, Left|
|42-5300-067-01||Persona Two-Peg Trabecular Metal™ Tibia, TM Size D, Left|
|42-5300-071-01||Persona Two-Peg Trabecular Metal™ Tibia, TM Size E, Left|
|42-5300-075-01||Persona Two-Peg Trabecular Metal™ Tibia, TM Size F, Left|
|42-5300-079-01||Persona Two-Peg Trabecular Metal™ Tibia, TM Size G, Left|
|42-5300-083-01||Persona Two-Peg Trabecular Metal™ Tibia, TM Size H, Left|
|42-5300-088-01||Persona Two-Peg Trabecular Metal™ Tibia, TM Size J, Left|
|42-5300-064-02||Persona Two-Peg Trabecular Metal™ Tibia, TM Size C, Right|
|42-5300-067-02||Persona Two-Peg Trabecular Metal™ Tibia, TM Size D, Right|
|42-5300-071-02||Persona Two-Peg Trabecular Metal™ Tibia, TM Size E, Right|
|42-5300-075-02||Persona Two-Peg Trabecular Metal™ Tibia, TM Size F, Right|
|42-5300-079-02||Persona Two-Peg Trabecular Metal™ Tibia, TM Size G, Right|
|42-5300-083-02||Persona Two-Peg Trabecular Metal™ Tibia, TM Size H, Right|
|42-5300-088-02||Persona Two-Peg Trabecular Metal™ Tibia, TM Size J, Right|
*Due to length and detail, some other information was omitted from the Notice to relevant medical providers by Zimmer.
If you have questions about your Zimmer Persona knee implant, please call Childers, Schlueter & Smith, LLC to discuss your legal rights. Our Persona knee implant lawyers are standing by to answer all of your questions. All inquiries are kept completely confidential and all initial consults are free of charge. We can be reached at 1-800-641-0098