BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 52ODX46ID

    MDR report key: 6868016 · Received September 15, 2017

    Report

    Report Number
    0001825034-2017-07076
    Event Type
    Injury
    Date Received
    September 15, 2017
    Date of Event
    May 8, 2015
    Report Date
    September 26, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034-2016-04033. CONCOMITANT MEDICAL PRODUCTS - P/N 157446 M2A-MAGNUM MOD HD SZ 46M L/N 170300, P/N 00771100900 FEMORAL STEM 12/14 NECK TAPER L/N 63594642, P/N US157852 M2A-MAGNUM PF CUP 52ODX46ID L/N 134830, P/N 103203 TAPERLOC POR FMRL 9X137 L/N 560380, P/N 139254 M2A-MAGNUM 42-50 MM TPR INSRT-3 L/N 568040. THE DEVICE HAS NOT BEEN RETURNED FOR MANUFACTURER EVALUATION AT THIS TIME. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES. REVIEW OF THE REVISION OPERATIVE NOTES FROM (B)(6) 2015 DETERMINED THE POSTOPERATIVE DIAGNOSIS TO BE ASEPTIC LOOSENING OF THE ACETABULAR COMPONENT. IT WAS NOTED THE PATIENT NEVER EXPERIENCED AN EPISODE WHERE SHE WAS PAIN FREE FOLLOWING THE INITIAL SURGERY. THE MAJORITY OF THE PAIN WAS IN THE GROIN. THE ACETABULAR COMPONENT HAD SOME EVIDENCE OF SPOT BONDING, BUT THE MAJORITY OF THE CUP APPEARED TO BE A FIBROUS UNION TO THE ACETABULUM AND THE CUP WAS REMOVED WITH MINIMAL BONE DAMAGE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS REVISED DUE GROIN PAIN SECONDARY TO ASCETIC LOOSENING OF THE ACETABULAR COMPONENT. THE PATIENT WAS HAVING ISSUES WEIGHT BEARING AND DIFFICULTY WITH MOVEMENT. NO EVIDENCE OF INFECTION WAS IDENTIFIED PRE-OPERATIVELY. UPON ENTRY INTO THE JOINT SPACE, THE ACETABULAR COMPONENT SHOWED EVIDENCE OF SPOT BONDING, BUT THE MAJORITY OF THE ACETABULAR COMPONENT APPEARED TO HAVE ONLY FIBROUS TISSUE UNION TO THE ACETABULUM. THE CUP WAS REMOVED WITH MINIMAL BONE DAMAGE. NO COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS REVISED DUE TO GROIN PAIN SECONDARY TO ASCETIC LOOSENING OF THE ACETABULAR COMPONENT. THE PATIENT WAS HAVING ISSUES WEIGHT BEARING AND DIFFICULTY WITH MOVEMENT. NO EVIDENCE OF INFECTION WAS IDENTIFIED PRE-OPERATIVELY. UPON ENTRY INTO THE JOINT SPACE, THE ACETABULAR COMPONENT SHOWED EVIDENCE OF SPOT BONDING, BUT THE MAJORITY OF THE ACETABULAR COMPONENT APPEARED TO HAVE ONLY FIBROUS TISSUE UNION TO THE ACETABULUM. THE CUP WAS REMOVED WITH MINIMAL BONE DAMAGE. A NEW HEAD, LINER, AND CUP WERE USED TO COMPLETE THE PROCEDURE. NO COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649941 M2A-MAGNUM PF CUP 52ODX46ID PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 134830

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R