BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC POR LAT FMRL 9X137

    MDR report key: 9902640 · Received March 31, 2020

    Report

    Report Number
    0001825034-2020-01352
    Event Type
    Injury
    Date Received
    March 31, 2020
    Date of Event
    August 21, 2018
    Report Date
    March 31, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 157446 M2A-MAGNUM MOD HD SZ 46MM 46MM 834180, 139256 M2A-MAGNUM 42-50 TPR INSRT STD 011950, ABX-US157852 52ODX46ID MAGNUM ABX PF CUP 774990. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-04932 HEAD, 0001825034-2019-04934 NECK. 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 CONFIRM THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO HEMATOMA, TISSUE DAMAGE AND PAIN. THE STEM, HEAD AND TAPER ADAPTER WERE EXPLANTED AND REPLACED. PATIENT UNDERWENT A SECOND REVISION DUE TO PAIN AND HETEROTOPIC OSSIFICATION. DURING THE PROCEDURE IT WAS NOTED THAT THE PATIENT HAS GOT A LITTLE BIT OF HETEROTOPIC OSSIFICATION AND SOME OFF THE GREATER TROCHANTER AND THEN A GLUTEUS AREA. SOME REACTIVE TISSUE NOTED BUT NO EVIDENCE OF INFECTION OR PSEUDOTUMOR. SHELL AND STEM WELL FIXED AND LEFT IN PLACE, ACTIVE ARTICULATION SYSTEM PLACED WITHOUT COMPLICATION. 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 · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL LEFT HIP REPLACEMENT. THE PATIENT¿S FEMORAL COMPONENTS WERE REVISED APPROXIMATELY TEN DAYS LATER DUE TO PAIN, HEMATOMA, AND ABDUCTOR FRAYING. THE PATIENT UNDERWENT A SECOND REVISION APPROXIMATELY TWELVE YEARS LATER DUE TO PAIN AND HETEROTOPIC OSSIFICATION. DURING THE REVISION, SOME REACTIVE TISSUE WAS NOTED, BUT NO EVIDENCE OF FURTHER COMPLICATIONS. THE SHELL AND STEM WERE WELL-FIXED AND LEFT INTACT. AN ACTIVE ARTICULATION SYSTEM WAS PLACED WITHOUT COMPLICATION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366428 TAPERLOC POR LAT FMRL 9X137 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 359020

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R