BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 52-60MM TPR INSRT-3 0/-3MMT1

    MDR report key: 14879010 · Received June 30, 2022

    Report

    Report Number
    0001825034-2022-01537
    Event Type
    Injury
    Date Received
    June 30, 2022
    Date of Event
    October 6, 2021
    Report Date
    August 4, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K101336
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CAT#157862 LOT#711790 M2A-MAGNUM RECAP CUP, CAT# 157456 LOT# 339460 M2A-MAGNUM MOD HD, CAT# 192017 LOT# 220590 ECHO POR FMRL. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-01536, 0001825034-2022-01538.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED DUE TO THE REVIEW OF MEDICAL RECORDS. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED FINDINGS OF THE REPORTED ISSUES. PARTIAL TEAR OF GLUTEUS MEDIUS, HO, COBALT LEVEL 7.8, CHROMIUM 5.7, SYNOVITIS AND FLUID WITH DISCOLORATION, STEM WELL FIXED NO INTRA-OP COMPLICATIONS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. UPON REASSESSMENT OF THE REPORTED EVENT, THE TAPER INSERT WAS DETERMINED TO BE NOT REPORTABLE AS THE DEVICE IS NOT BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED. 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

    IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 11 YEARS POST IMPLANTATION DUE TO METALLOSIS AND PROGRESSIVE PAIN. DURING THE REVISION, A CHRONIC PARTIAL TEAR OF THE GLUTEUS MEDIUS WAS FOUND WITH A SMALL HETEROTOPIC BONE FRAGMENT ATTACHED, FROM OSSIFICATION. A SYNOVECTOMY WAS PERFORMED AROUND THE HIP WITH SYNOVITIS NOTED AROUND THE GREATER TROCHANTER. NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THE TAPER INSERT WAS DETERMINED TO BE NOT REPORTABLE AS THE DEVICE IS NOT BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431227 M2A-MAGNUM 52-60MM TPR INSRT-3 0/-3MMT1 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 687000

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H SEE H10 NARRATIVE.