BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIV RNGLC SHL 60MM/L23

    MDR report key: 10779444 · Received November 3, 2020

    Report

    Report Number
    0001825034-2020-03997
    Event Type
    Injury
    Date Received
    November 3, 2020
    Report Date
    November 3, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K921301
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: 163665 28MM DIA COCR MOD HD +9MM 578400; 12-105903 RNGLC +5MM LNR 28MM HWALL SZ23 974220; ITEM #: UNKNOWN UNKNOWN STEM LOT #: UNKNOWN; 113847 TITANIUM SCREW LOW PROF 5X35MM 298515; 113847 TITANIUM SCREW LOW PROF 5X35MM 298515; 103532 BM ACET LP DOME SCW TI S/TAP D IA6.5X25MM 206010; 103532 BM ACET LP DOME SCW TI S/TAP D IA6.5X25MM 586140. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE PRODUCT REMAINS IMPLANTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2020 - 03286, 0001825034 - 2020 - 03287, 0001825034 - 2020 - 03998. 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. RADIOGRAPHS IDENTIFIED THE FOLLOWING: THE ARTHROPLASTY COMPONENTS ARE ANATOMICALLY ALIGNED WITHOUT DISLOCATION OR FRACTURE. THERE IS EXTENSIVE OSTEOLYSIS GREATEST IN GRUEN ZONES 1 AND 7 OF THE FEMORAL IMPLANT AND AT THE INFERIOR ACETABULAR CUP, AS WELL AS QUESTIONABLY ALONG THE MORE LATERAL CUP FIXATION SCREW. EXTENSIVE OSTEOLYSIS OF THE LEFT HIP ARTHROPLASTY. 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 BY THE 411 GROUP THE PATIENT UNDERWENT AN INITIAL THA AT AN UNKNOWN DATE. THE PATIENT HAS BEEN INDICATED FOR A REVISION, HOWEVER, A REVISION HAS NOT BEEN REPORTED. RADIOGRAPHS IDENTIFIED EXTENSIVE OSTEOLYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1244230 UNIV RNGLC SHL 60MM/L23 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 353810

    Patients

    Seq Age Sex Outcome Treatment
    1 Other