BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALL-POLY PATELLA CEMENTED

    MDR report key: 16642783 · Received March 30, 2023

    Report

    Report Number
    0002648920-2023-00057
    Event Type
    Injury
    Date Received
    March 30, 2023
    Date of Event
    March 10, 2023
    Report Date
    May 5, 2023
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    UDI-DI
    00889024247680
    PMA / PMN Number
    K121771
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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. VISUAL EVALUATION OF THE PROVIDED PICTURES SHOWS THE PATELLA IMPLANT AS FRACTURED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. MEDICAL RECORDS AND RADIOGRAPHS REVIEW INDICATES REVISION - PATELLA RESURFACING AND TIBIAL INSERT, PATELLA FRACTURE DERIDED WITH SOME WEAR NOTED AT FRACTURE EDGE, NO SIGNS OF LOOSENING, WEAR OR RADIOLUCENCY, MILDLY DISTRACTED FRACTURE OF THE MID PATELLA. 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

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: FEMUR CEMENTED CRUCIATE RETAINING (CR) NARROW RIGHT SIZE 8 CATALOG # 42502006402 LOT # 63946336, TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE E CATALOG # 42532007102 LOT # 64562873, ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 12 MM HEIGHT USE WITH TIBIA SIZES E-F/CR FEMUR SIZES 8-11 CATALOG # 42522100812 LOT # 64279902, PALACOS MV+G CATALOG # 66031993 LOT # 95324925, PALACOS MV+G CATALOG # 66031993 LOT # 95324925. REPORT SOURCE: AUSTRALIA. REPORTER HAD INDICATED THAT PRODUCT WILL NOT BE RETURNED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE TWO YEARS POST IMPLANTATION DUE TO PATELLA PERIPROSTHETIC FRACTURE AND PAIN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE TWO YEARS POST IMPLANTATION DUE TO PAIN AND FRACTURED PATELLA. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210294 ALL-POLY PATELLA CEMENTED PROSTHESIS KNEE JWH ZIMMER MANUFACTURING B.V. N/A 64621833 00889024247680

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H