BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OSS LOCK PIN

    MDR report key: 11100271 · Received December 31, 2020

    Report

    Report Number
    0001825034-2020-04459
    Event Type
    Injury
    Date Received
    December 31, 2020
    Date of Event
    July 6, 2020
    Report Date
    December 30, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ASSOCIATED PRODUCTS : ITEM# 150392; OSS POROUS IM STEM 13.5 X 150; LOT# 987470. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-02876. THE LOCK PIN WAS NOT RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEATH CARE PROFESSIONAL. REVIEW FOUND PATIENT HAD PAIN, DIFFICULTY WITH ACTIVITIES OF DAILY LIVING INCLUDING GETTING OUT OF A CHAIR, AMBULATING DISTANCES AND STAIRS. X-RAYS SHOW FEMORAL STEM FRACTURE. INTRA-OP NOTES FOUND THE LOCK PIN WAS ALSO BROKEN AND EVIDENCE OF METALLOSIS IN THE KNEE TISSUE AND SYNOVIUM. FEMORAL COMPONENT WAS GROSSLY LOOSE AND EASILY REMOVED WITH SIGNIFICANT AMOUNT OF OSTEOLYSIS. TIBIA WAS WELL FIXED. NO COMPLICATIONS NOTED. ROOT CAUSE CANNOT BE DETERMINED. 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 · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED AS THE FEMORAL STEM AND LOCKING PIN BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1567093 UNKNOWN OSS LOCK PIN PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R