BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMUR TRABECULAR METAL CRUCIATE RETAINING (CR)

    MDR report key: 14474716 · Received May 23, 2022

    Report

    Report Number
    0001822565-2022-01499
    Event Type
    Injury
    Date Received
    May 23, 2022
    Date of Event
    April 29, 2022
    Report Date
    May 23, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    OIY
    UDI-DI
    00889024230774
    PMA / PMN Number
    K172524
    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). MEDICAL PRODUCT: ARTICULAR SURFACE MEDIAL CONGRUENT (MC) CATALOG # 42512100514 LOT # 64267672, 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. (B)(4). REPORT SOURCE: (B)(6). MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 3007963827-2022-00148. 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
    1676436 FEMUR TRABECULAR METAL CRUCIATE RETAINING (CR) PROSTHESIS KNEE OIY ZIMMER BIOMET, INC. N/A 64259934 00889024230774

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R