BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50 TPR INSRT STD

    MDR report key: 9271325 · Received November 4, 2019

    Report

    Report Number
    0001825034-2019-04934
    Event Type
    Injury
    Date Received
    November 4, 2019
    Date of Event
    August 21, 2018
    Report Date
    March 31, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K101336
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, B5, B7, G4, H2, H3, H6. AN ADDITIONAL MDR REPORT WAS FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034 - 2020 - 01352 STEM. 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 · 0

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 157446 M2A-MAGNUM MOD HD SZ 46MM 834180, 11-103204 TAPERLOC POR FMRL LAT 10X140 301630, ABX-US157852 52ODX46ID MAGNUM ABX PF CUP 774990. 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 -2019 -04932 HEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED BY LEGAL COUNSEL THAT THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY THAT WAS FIRST REVISED A MONTH AFTER IMPLANTATION. A SECOND REVISION OCCURRED ELEVEN YEARS LATER DUE TO PAIN. SIGNS OF HETEROTOPIC OSSIFICATION WERE FOUND. DOCTOR DECIDED TO REVISE THE METAL-ON-METAL TO A POLYETHYLENE HIP AS THE BEST OPTION. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1067866 M2A-MAGNUM 42-50 TPR INSRT STD PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 011950

    Patients

    Seq Age Sex Outcome Treatment
    1