BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS 3CM RESURFACING RT

    MDR report key: 18761395 · Received February 22, 2024

    Report

    Report Number
    0001825034-2024-00494
    Event Type
    Injury
    Date Received
    February 22, 2024
    Date of Event
    February 5, 2024
    Report Date
    May 1, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K141331
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - MEDICAL PRODUCT: OSS CEMENTED IM STEM 16X150 CATALOG # 150370 LOT # 067110 OSS POLY FEMORAL BUSHINGS CATALOG # 150477 LOT # 378090 OSS POLY TIBIAL BUSHING CATALOG # 150476 LOT # 438170 PALACOS R 1X40 SINGLE CATALOG # 00111214001 LOT # 87794709 PALACOS RG 1X40 SINGLE CATALOG # 00111314001 LOT # 87424699 OSS REINFORCED YOKE CATALOG # 150493 LOT # 113520 OSS MOD TIB BASEPLATE 71MM CATALOG # 150422 LOT # 993770 OSS TIB BLK AUG 10X71/75 UNIV CATALOG # 150427 LOT # 683320 OSS TIBIAL POLY BEARING 16MM CATALOG # 150412 LOT # 380610 PALACOS RG 1X40 SINGLE CATALOG # 00111314001 LOT # 89344763 OSS AXLE CATALOG # 150480 LOT # 336910 OSS CEMENTED IM STEM 12MMX90MM CATALOG # 150361 LOT # 092530 OSS POLY LOCK PIN CATALOG # 150478 LOT # 210660 H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE REQUESTED BUT NOT RETURNED BY HOSPITAL. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034-2024-00496 H3 OTHER TEXT : NOT RETURNED BY HOSPITAL

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE H6: MECHANICAL (G04) - FEMUR. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. 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. X-RAY REVIEW INDICATES THERE IS HINGED PROSTHESIS RIGHT TOTAL KNEE ARTHROPLASTY WITH SIGNIFICANT LOOSENING OF THE FEMORAL COMPONENT. OSTEOPENIA IS PRESENT. 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 FIVE YEARS POST IMPLANTATION DUE TO FEMORAL LOOSENING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114967 OSS 3CM RESURFACING RT PROSTHESIS KNEE JDI ZIMMER BIOMET, INC. N/A 462860

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H SEE H10 NARRATIVE