BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 58OD/52ID

    MDR report key: 6686349 · Received July 5, 2017

    Report

    Report Number
    0001825034-2017-04434
    Event Type
    Injury
    Date Received
    July 5, 2017
    Date of Event
    July 1, 2015
    Report Date
    December 21, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE ZIMMER BIOMET DEIVCE DID NOT CONTRIBUTED TO THE EVENT AND IT DETERMINED IS NOT REPORTABLE. HENCE THE INITIAL REPORT SUBMITTED NEEDS TO BE VOIDED.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE ZIMMER BIOMET DEIVCE DID NOT CONTRIBUTED TO THE EVENT AND IT DETERMINED IS NOT REPORTABLE. HENCE THE INITIAL REPORT SUBMITTED NEEDS TO BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOMET TAPERLOC FEMORAL STEM P/N 103205 L/N 156740; BIOMET M2A MAGNUM TAPER INSERTER P/N 139270 L/N 228410; BIOMET M2A MAGNUM MODULAR HEAD P/N 157452 L/N 972810. THE EVENT WAS CONFIRMED WITH MEDICAL RECORDS RECEIVED. PREOP CULTURES RETURNED (B)(6) FOR (B)(6). ACETABULAR SHELL NOTED TO BE GROSSLY LOOSE. FEMORAL COMPONENT REMOVED WITH VERY LITTLE EFFORT [LOOSE]. ALL ZB COMPONENTS REMOVED, 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-11452.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-11452.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. A M2A-MAGNUM PF CUP 58OD/52ID, PART # US157858 FROM LOT 691400, WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. VISUAL INSPECTION FOUND THE INNER RADIUS OF THE CUP TO BE SCRATCHED CONSISTENT WITH METAL ON METAL CONSTRUCTION. HAZY DISCOLORATION WAS ALSO OBSERVED ON THE INNER RADIUS. DISCOLORATION AND DEBRIS WERE OBSERVED ON THE OUTER RADIUS OF THE CUP. A SECTION OF THE POROUS COATING HAS CHIPPED AWAY FROM THE CUP. ADDITIONAL INFORMATION DID NOT CHANGE THE OUTCOME OF THE PREVIOUS INVESTIGATION. 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 · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ADDITIONAL INFORMATION DID NOT CHANGE THE OUTCOME OF THE PREVIOUS INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS - BIOMET TAPERLOC FEMORAL STEM P/N 103205 L/N 156740; BIOMET M2A MAGNUM TAPER INSERTER P/N 139270 L/N 228410; BIOMET M2A MAGNUM MODULAR HEAD P/N 157452 L/N 972810.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A RIGHT REVISION PROCEDURE APPROXIMATELY FIVE YEARS POST-IMPLANTATION DUE TO LOOSENING AND (B)(6) INFECTION. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A RIGHT REVISION PROCEDURE APPROXIMATELY FIVE YEARS POST-IMPLANTATION DUE TO PAIN, DISCOMFORT, LACK OF MOBILITY, LOOSENING, TISSUE DESTRUCTION, BONE DESTRUCTION, METAL WEAR AND METAL POISONING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A RIGHT REVISION PROCEDURE APPROXIMATELY FIVE YEARS POST-IMPLANTATION DUE TO LOOSENING, ELEVATED METAL ION LEVELS AND (B)(6) INFECTION. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT RECEIVED A RIGHT REVISION PROCEDURE FIVE YEARS POST-IMPLANTATION DUE TO PAIN, DISCOMFORT, LACK OF MOBILITY, AND LOOSENING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468946 M2A-MAGNUM PF CUP 58OD/52ID PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 691400

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R