BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 FP TYPE1 PPS SO 7.0

    MDR report key: 12913767 · Received December 1, 2021

    Report

    Report Number
    0001825034-2021-03175
    Event Type
    Injury
    Date Received
    December 1, 2021
    Date of Event
    November 1, 2021
    Report Date
    March 21, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWL
    UDI-DI
    00880304489653
    PMA / PMN Number
    K200196
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS AND X-RAYS PROVIDED. A REVIEW OF THE AVAILABLE MEDICAL RECORDS IDENTIFIED FINDINGS OF THE REPORTED ISSUES. PATIENT-REPORTED PAIN RATED AT A 2. X-RAY CONFIRMED STEM SUBSIDENCE, MIGRATION, LOOSENING, AND FAILURE OF INGROWTH. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). BIOLOX CERAMIC 32MM HEAD +0MM NECK, 12-115115, LOT 2970956. CROSSLINKED STANDARD LINER, 00-6305-048-32, LOT 6423176. SCREW, 00-6250-065-30, LOT J6842333. SCREW, 00-6250-065-20, LOT J6773626. TRILOGY CLUSTER, 48MM 00-6200-048-22, LOT 63234345. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION; DUE TO THE DEVICE WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT INITIAL HIP ARTHROPLASTY, SUBSEQUENTLY; THE PATIENT WAS REVISED APPROXIMATELY ONE YEAR POST IMPLANTATION DUE TO DUE TO ASEPTIC LOOSENING OF THE FEMORAL STEM. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1806633 TPRLC 133 FP TYPE1 PPS SO 7.0 PROSTHESIS, HIP KWL ZIMMER BIOMET, INC. N/A 6851040 00880304489653

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R SEE H10 NARRATIVE