BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULAR SURFACE MEDIAL CONGRUENT (MC)

    MDR report key: 14474574 · Received May 23, 2022

    Report

    Report Number
    3007963827-2022-00148
    Event Type
    Injury
    Date Received
    May 23, 2022
    Date of Event
    April 29, 2022
    Report Date
    May 23, 2022
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    MBH
    UDI-DI
    00889024469099
    PMA / PMN Number
    K150090
    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

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: FEMUR TRABECULAR METAL CRUCIATE RETAINING (CR) CATALOG# 42502806401, LOT# 64259934. INSET ALL-POLY PATELLA CEMENTED 26 MM DIAMETER CATALOG# 42540200026, LOT# 64775962. ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 10 MM HEIGHT USE WITH TIBIA SIZES C-D/CR FEMUR SIZES 8-9 CATALOG# 42512100510 LOT# 64463436. DEPUY CMW 2 BONE CEMENT CATALOG# 3322-040, LOT 8723770. NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE D CATALOG# 42530006701, LOT# 64517314. FOREIGN: (B)(6). MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001822565-2022-01499. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE WAS NOT RETURNED. VISUAL EVALUATION OF THE PROVIDED PICTURES IDENTIFIED A FEMORAL AND ARTICULAR SURFACE, BOTH ARE COVERED IN A FOREIGN MATERIAL. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE SEVENTEEN MONTHS POST IMPLANTATION DUE TO INSTABILITY. 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
    165749 ARTICULAR SURFACE MEDIAL CONGRUENT (MC) PROSTHESIS KNEE MBH ZIMMER ORTHOPAEDIC MFG. LTD. N/A 64267672 00889024469099

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R