BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10 NARRATIVE

    MDR report key: 16938326 · Received May 16, 2023

    Report

    Report Number
    0001822565-2023-01301
    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
    00887868249594
    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

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED AS THIS PRODUCT WAS NOT IMPLANTED DURING PROCEDURE. CORRECT PRODUCT WILL BE COMPLETED UNDER MANUFACTURING REPORT NUMBER 0001822565-2023-02550.

    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#: 42560007514, LOT#: 65032365, MANUFACTURE DATE: FEB 22, 2021, STERILE EXPIRY DATE: FEB 14, 2031, UDI: (B)(4), 510K: K191625 PRO CODE: JWH. OR ITEM#: 42560007514, LOT#: 65033946, MANUFACTURE DATE: FEB 22, 2021, STERILE EXPIRY DATE: FEB 16, 2031, UDI: (B)(4), 510K: K191625 PRO CODE: JWH. OR ITEM#: 42560113510, LOT#: 64911578, MANUFACTURE DATE: NOV 30, 2020, STERILE EXPIRY DATE: NOV 21, 2030, UDI: (B)(4), 510K: K181947 PRO CODE: OIY. D10: MEDICAL PRODUCT: FEMORAL CENTRAL CONE, CATALOG # 42545001012, LOT# 64700341. TIBIA FIXED CEMENTED STEM EXTENSION, CATALOG # 42542006701, LOT# 64960941. 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, 0001822565-2023-01300, 0001822565-2023-01314.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED AS THIS PRODUCT WAS NOT IMPLANTED DURING PROCEDURE. CORRECT PRODUCT WILL BE COMPLETED UNDER MANUFACTURING REPORT NUMBER 0001822565-2023-02550.

    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
    1351509 SEE H10 NARRATIVE PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 65032365 00887868249594

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other SEE H10 NARRATIVE