BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA ALL POLY PATELLA

    MDR report key: 14944857 · Received July 7, 2022

    Report

    Report Number
    0002648920-2022-00147
    Event Type
    Injury
    Date Received
    July 7, 2022
    Report Date
    November 11, 2022
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    UDI-DI
    00889024247628
    PMA / PMN Number
    K113369
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MEDICAL PRODUCT: CEMENTED PATELLO-FEMORAL TROCHLEA COMPONENT CATALOG # 00592601202 LOT # 63675799. UNKNOWN CEMENT CATALOG # UNKNOWN LOT # UNKNOWN. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001822565-2022- 01897. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS PROVIDED. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THE ROOT CAUSE OF THE ALLERGIC REACTION IS ATTRIBUTED TO PATIENT CONDITION AS THE FEMORAL COMPONENT CONTAINS NICKEL. PER INSTRUCTIONS FOR USE 87-6203-757-23 REV D (ZIMMER GENDER SOLUTIONS PATELLO-FEMORAL JOINT) ASSOCIATED WITH PRODUCT ITEM#: 00592601202, IT STATES 'USE ONLY NEXGEN ALL-POLYETHYLENE, POROUS OR AUGMENTATION PATELLAS OR GENDER SOLUTIONS NATURAL-KNEE FLEX ALL-POLYETHYLENE OR METAL-BACKED PATELLAS WITH THE ZIMMER GENDER SOLUTIONS PATELLO-FEMORAL JOINT (PFJ) PROSTHESIS IF RESURFACING THE PATELLA. PATELLAS MADE FOR OTHER SYSTEMS MAY DEMONSTRATE EXCESSIVE WEAR WHEN USED WITH THESE FEMORAL COMPONENTS' IT IS UNKNOWN IF THIS COMBINATION OF PRODUCTS ARE CONTRIBUTING TO THE REPORTED ISSUE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED FOR THE PAIN THE PATIENT EXPERIENCES. MEDICAL RECORDS REVIEW INDICATES (B)(6) 2022 ORTHOPEDIC ANALYSIS: HIGHLY REACTIVE TO NICKEL 9.2 AND KNOWN STIMULANT (PHA) 26.7. HIGHLY REACTIVE IS ABOVE 8. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT IS EXPERIENCING PAIN AND DECREASED ACTIVITY POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1501354 PERSONA ALL POLY PATELLA PROSTHESIS KNEE JWH ZIMMER MANUFACTURING B.V. N/A 63586421 00889024247628

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other SEE H10 NARRATIVE