BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP CMT FMRL HD RESUR 50M

    MDR report key: 7884708 · Received September 18, 2018

    Report

    Report Number
    0001825034-2018-08716
    Event Type
    Injury
    Date Received
    September 18, 2018
    Date of Event
    June 4, 2018
    Report Date
    April 4, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KXA
    PMA / PMN Number
    PK021799
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DHR 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. CONCOMITANT MEDICAL PRODUCTS: US157856, M2A-MAGNUM PF CUP 56ODX50ID, 893550. REPICCI FMRL 54MM RM/LL102120, 792370. 102150, REPICCI TIBIAL 37X6.5MM, 054860. 902929, HARPOON SIZE 2 SUTURE, 775000.

    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 THAT THE PATIENT'S RIGHT HIP WAS REVISED APPROXIMATELY 13 YEARS POST IMPLANTATION DUE TO PAIN AND ELEVATED METAL IONS. THERE WAS EVIDENCE THAT PART OF THE ANTERIOR REPAIR OF THE ABDUCTORS FROM A PRIOR SURGERY HAD AVULSED. THIS APPEARED CHRONIC. THERE WAS SOME BROWNISH STAINING OF THE TISSUES IN THE AREA AND MILD BROWNISH DISCOLORATION OF THE ANTERIOR CAPSULAR AREA. ALL ZIMMER BIOMET PRODUCTS WERE REMOVED AND REPLACED WITH STRYKER PRODUCTS.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 102120, REPICCI FMRL 54MM RM/LL792370; 102150, REPICCI TIBIAL 37X6.5MM, 54860; US157856, M2A-MAGNUM PF CUP 56ODX50ID, 893550. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-08717. 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'S RIGHT HIP WAS REVISED APPROXIMATELY 13 YEARS POST IMPLANTATION DUE TO PAIN AND ELEVATED METAL IONS. THERE WAS EVIDENCE THAT PART OF THE ANTERIOR REPAIR OF THE ABDUCTORS FROM A PRIOR SURGERY HAD AVULSED. THIS APPEARED CHRONIC. THERE WAS SOME BROWNISH STAINING OF THE TISSUES IN THE AREA AND MILD BROWNISH DISCOLORATION OF THE ANTERIOR CAPSULAR AREA. NO ADDITIONAL INFORMATION WAS MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726233 RECAP CMT FMRL HD RESUR 50M PROSTHESIS, HIP KXA ZIMMER BIOMET, INC. N/A 789720

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R