BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIC SALVAGE SYSTEM (OSS) IM STEM WITH SCREW POROUS PLASMA CEMENTED

    MDR report key: 7877035 · Received September 14, 2018

    Report

    Report Number
    0001825034-2018-08829
    Event Type
    Injury
    Date Received
    September 14, 2018
    Date of Event
    December 7, 2018
    Report Date
    June 24, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K123501
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. UDI #: (B)(4). CONCOMITANT MEDICAL PRODUCTS : OSS LG OSSEOTI DIST FEM AUG CATALOG # 151854 LOT # 073250, OSS RS NON MOD PLATE LONG 63 CATALOG # 161038 LOT # 544740, OSS POLY FEMORAL BUSHINGS 2PK CATALOG # 150477 LOT # 972600, OSS POLY TIBIAL BUSHING CATALOG # 150476 LOT # 617360, OSS POLY LOCK PIN CATALOG # 150478 LOT # 324790, OSS AXLE CATALOG # 150480 LOT # 168970, OSS REINFORCED YOKE CATALOG # 150493 LOT # 220000, OSS 3CM RESURFACING RT CATALOG # 151805 LOT # 182140, OSS RS 12MM LS TIBIAL BEARING CATALOG # 161094 LOT # 319740.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY TWO YEARS POST-IMPLANTATION.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). 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. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS BEING SCHEDULED FOR A KNEE ARTHROPLASTY REVISION DUE FRACTURE KNEE. REPLACEMENT IMPLANT DEVICE IS REQUESTED FOR REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716859 ORTHOPEDIC SALVAGE SYSTEM (OSS) IM STEM WITH SCREW POROUS PLASMA CEMENTED PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 557920

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention