BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP

    MDR report key: 6926783 · Received October 7, 2017

    Report

    Report Number
    0001825034-2017-08094
    Event Type
    Injury
    Date Received
    October 7, 2017
    Date of Event
    July 10, 2017
    Report Date
    March 23, 2021
    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
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. A ACT ARTIC E1 HIP BRG 28X42MM, PART # EP-200148 FROM LOT 327820, WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. THE BEARING REMAINS ASSEMBLED WITH THE CERAMIC HEAD AND HEAD NECK TAPER UPON RECEIPT. VISUAL INSPECTION FOUND SCRATCHING AND INDENTATIONS IN THE OUTER RADIUS OF THE BEARING. A FEW OF THE INDENTATIONS CAN BE SEEN AS SCRATCHES WITH VISIBLE EDGES BUT OTHERS WERE WORN INTO THE BEARING OVER TIME. A M2A-MAGNUM PF CUP 50ODX44ID, PART # US157850 FROM LOT 810180, WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. VISUAL INSPECTION FOUND SCRATCHING AND SCUFFING INSIDE THE CUP. PORTIONS OF THE FINISH OF THE INNER RADIUS HAVE BECOME HAZY. THESE DEVICES ARE FUNCTIONALLY COMPATIBLE. HOWEVER, AN M2A MAGNUM PF CUP, LEFT FROM THE PRIMARY SURGERY WAS USED IN CONJUNCTION WITH A NEW ACTIVE ARTICULATION HIP BEARING. THIS WOULD BE CONSIDERED AN OFF-LABEL USE OF THESE DEVICES. HOWEVER IT IS UNKNOWN IF THIS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE ADDITIONAL INFORMATION DOES 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 REPORT 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. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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. CONCOMITANT MEDICAL PRODUCTS: PART: EP-200148, ACT ARTIC E1 HIP BRG 28X42MM, LOT: 327820. PART: US157850, M2A-MAGNUM PF CUP 50ODX44ID, LOT: 810180. PART: 650-1055, CER BIOLOXD OPTION HD 28MM, LOT: 327820. PART: 650-1068, CER OPTION TYPE 1 TPR SLEVE +6, LOT: 319180.

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTION AND ADDITIONAL INFORMATION. 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

    THE COMPLAINT NUMBER CORRESPONDING TO THIS MEDWATCH IS (B)(4). IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS:0001825034-2017-08095.

    Description of Event or Problem · 1

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

    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 FURTHER REPORTED BY PATIENT'S LEGAL COUNSEL THAT THE PATIENT HAS ALLEGEDLY EXPERIENCED MULTIPLE DISLOCATIONS WHICH REQUIRED A REVISION PROCEDURE.

    Description of Event or Problem · 1

    PATIENT SUFFERED FROM PAIN, TISSUE DESTRUCTION, BONE DESTRUCTION, METAL WEAR, METAL POISONING AND LIMITATION OF DAILY ACTIVITIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED APPROXIMATELY 6 MONTHS POST IMPLANTATION DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706412 M2A-MAGNUM PF CUP PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 810180

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R