BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIA FIXED CEMENTED LEFT SIZE D STEM EXTENSION

    MDR report key: 16938319 · Received May 16, 2023

    Report

    Report Number
    0001822565-2023-01300
    Event Type
    Injury
    Date Received
    May 16, 2023
    Date of Event
    April 17, 2023
    Report Date
    September 29, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00889024562783
    PMA / PMN Number
    K191625
    Removal / Correction Number
    N/A
    Adverse Event
    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. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D1, D4, G3, G4, G6, H1, H2, H3, H4, H6, H10. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE WAS NOT RETURNED. 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. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001822565-2023-02550, 0001822565-2023-02551, 0001822565-2023-02552.

    Additional Manufacturer Narrative · 0

    (B)(4). D4 - TWO DEVICE IDS WERE PROVIDED BY THE REPORTER; OF THESE, ONLY ONE (1) WAS REPORTED TO HAVE METAL ALLERGY. IT IS UNKNOWN WHICH EXACT DEVICE ENCOUNTERED THIS ISSUE, IT IS ONE OF THE FOLLOWING: ITEM#: 42542006701, LOT#: 64960941, MANUFACTURE DATE: MAR 29, 2021, STERILE EXPIRY DATE: MAR 22, 2031, UDI: (B)(4), 510K: K191625 PRO CODE: JWH. OR ITEM#: 42545000511 LOT#: 64815927, MANUFACTURE DATE: OCT 20, 2020, STERILE EXPIRY DATE: SEP 30, 2030, UDI: (B)(4), 510K: K191625 PRO CODE: JWH. D10 - MEDICAL PRODUCT: FEMORAL CENTRAL CONE CATALOG # 42545001012 LOT# 64700341; STEM EXTENSION TAPERED CEMENTED CATALOG # 4256007514 LOT# 65032365; FEMUR CEMENTED STANDARD CATALOG # 42504605401 LOT# 65046024; STEM EXTENSION CATALOG # 42560007514 LOT# 65033946; TIBIA CENTRAL CORE CATALOG # 42545000511 LOT# 64815927; FEMUR CEMENTED CATALOG # 42504605411 LOT# 65046008; STEM EXTENSION CATALOG # 42560113510 LOT# 64911578; ARTICULAR SURFACE CATALOG # 42512600414 LOT# 65321527; CABLE CERCLAGE CABLE CATALOG # 00223200418 LOT # 65240317; CABLE CERCLAGE CABLE CATALOG # 00223200418 LOT # 65240311; PALACOS R+G FAST CATALOG # 66056768 LOT # 99571117; PALACOS R+G FAST CATALOG # 66056768 LOT # 99571117; PALACOS R+G FAST CATALOG # 66056768 LOT # 99571117; FEMALE HEX SCREW CATALOG # 42509902525 LOT # 65259825. G2: AUSTRALIA. H3: 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. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001822565-2023-01299, 0001822565-2023-01301, 0001822565-2023-01314. H3 OTHER TEXT : REMAINS IMPLANTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT IS EXPERIENCING ALLERGY TO METAL EIGHT MONTHS POST IMPLANTATION. 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
    1351502 TIBIA FIXED CEMENTED LEFT SIZE D STEM EXTENSION PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 64960941 00889024562783

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other SEE H10 NARRATIVE