BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS FINN MOD PROX FMRL LT 7CM

    MDR report key: 11201910 · Received January 20, 2021

    Report

    Report Number
    0001825034-2021-00117
    Event Type
    Injury
    Date Received
    January 20, 2021
    Date of Event
    January 4, 2019
    Report Date
    June 2, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D11: 650-1055 BOLOLXD HEAD 428120 650-1066 SLEVE TAPER 779450 150393 STEM 249710 87-3435 DEPUY LINER 7930873 ITEM #: UNKNOWN COMPETITOR CUP LOT #: UNKNOWN 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

    (B)(6). REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. MEDICAL RECORDS/RADIOGRAPHS IDENTIFIED THE FOLLOWING: 46YO. DOING NORMAL ADLS, AND SUDDEN INABILITY TO WEIGHT BEAR, FELT SNAP OR POP IN HIP, TAKEN TO ER, FOUND IMPLANT HAD FRACTURED; PATIENT STATES LLD AND DIFFICULTY AMBULATING. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT THA ON AN UNKNOWN DATE. THE PATIENT WAS REVISED SEVERAL TIMES PRIOR TO THE REVISION FOR A FRACTURED FEMORAL STEM BODY. DURING THE PROCEDURE, IT WAS FOUND THAT THE BODY WAS COLD WELDED TO THE DISTAL STEM. IN THE ATTEMPT TO DISENGAGE THE BODY FROM THE STEM, THE STEM WAS ALSO FRACTURED AND HAD TO BE REPLACED. LEG LENGTH WAS ADDRESSED WITH THE NEW STEM AND THE FEMUR WAS CABLED TO AVOID FRACTURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM #: UNKNOWN UNKNOWN HEAD LOT #: UNKNOWN. ITEM #: UNKNOWN UNKNOWN LINER LOT #: UNKNOWN. ITEM #: UNKNOWN UNKNOWN CUP LOT #: UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY LEGAL DEPARTMENT THAT PATIENT UNDERWENT OSS PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT CLAIMS THE METAL STEM OF THEIR BIOMET OSS HIP IMPLANT SNAPPED IN HALF WHILE SITTING ON THE SOFA. PATIENT WAS TAKEN TO THE ER AND REVISED. PATIENT ALLEGES THAT THEIR LEFT LEG IS NOW ONE INCH SHORTER THAN THE RIGHT ONE AND THEY ARE IN CONSTANT AND INTENSE PAIN. MOBILITY IS A CHALLENGE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101747 OSS FINN MOD PROX FMRL LT 7CM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 231590

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R