BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M/H RADIAL SOLID/APX SHL 52MM

    MDR report key: 8366285 · Received February 25, 2019

    Report

    Report Number
    0001825034-2019-00798
    Event Type
    Injury
    Date Received
    February 25, 2019
    Date of Event
    December 14, 2017
    Report Date
    March 5, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    K921181
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. INITIAL OP NOTES SHOWED THERE WAS NO COMPLICATIONS DURING THE PROCEDURE. THE REVISION OP NOTES CONFIRMED THE METALLOSIS , LINER AND LOCKING RING FRACTURE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 32MM MOD HEAD COCR -3MM NECK # ITEM 163668 LOT 439330; EPOLY 32MM RLC LNR MROM SZ23 # ITEM EP-105933 LOT 802320; TPRLC 133 FP TYPE1 PPS HO 8.0 # ITEM 51-101080 LOT 3237346. REPORT SOURCE - (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-00796. IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND 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 THAT THE PATIENT UNDERWENT REVISION PROCEDURE APPROXIMATELY THREE YEARS POST INITIAL SURGERY DUE TO PAIN, MOBILITY DIFFICULTIES AND UNEVEN WEAR OF THE LINER. DURING THE SURGERY THE SURGEON FOUND THAT THE RING OF THE CUP AND LINER'S PERIPHERAL EDGE HAS FRACTURED AND THE LINER PARTIALLY DISLODGED FROM THE CUP. HE ALSO FOUND EXTENSIVE METALLOSIS IN THE SURROUNDING TISSUES DUE TO METAL HEAD RUBBING ON THE EDGES OF THE EXPOSED METAL CUP. LINER, FEMORAL HEAD AND RING WERE REVISED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160714 M/H RADIAL SOLID/APX SHL 52MM PROSTHESIS HIP LZO ZIMMER BIOMET, INC. N/A 479540

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R