BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 48ODX42ID

    MDR report key: 7396650 · Received April 4, 2018

    Report

    Report Number
    0001825034-2018-02288
    Event Type
    Injury
    Date Received
    April 4, 2018
    Date of Event
    March 14, 2016
    Report Date
    January 30, 2019
    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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD 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 - 02291 - 3, 0001825034 - 2018 - 02290 - 4.

    Additional Manufacturer Narrative · 0

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. THE PREVIOUS REPORT (0001825034-2018-02288-1) WAS VOIDED, AS THE DEVICE WAS PREVIOUSLY NOT RELATED TO THE EVENT. HOWEVER, ADDITIONAL INFORMATION WAS RECEIVED, AND IT HAS BEEN DETERMINED THE DEVICE IS INDEED RELATED TO THE EVENT. ITEM # 157442, HEAD, LOT # 206990. ITEM # 103204, FEMORAL STEM, LOT # 880720 ITEM # 139254, TAPER INSERT, LOT # 823380 G3: LEGAL NOTIFICATION MULTIPLE REPORTS HAVE BEEN SUBMITTED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-02291, 0001825034-2018-02290, 0001825034-2018-02288

    Description of Event or Problem · 0

    NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 7.5 YEARS POST IMPLANTATION DUE TO PAIN, ELEVATED ION LEVELS, METALLOSIS, OSTEOLYSIS OF THE ACETABULUM, AND CORROSION. OP NOTES INDICATED FLUID FILLED CYST THAT EXTENDED DOWN TO THE JOINT SPACE. LIGHTLY STAINED METALLIC DEBRIS NOTED AND EXCISED WITH DEBRIDEMENT OF GRANULOMATOUS APPEARING TISSUE AND METAL STAINING THROUGHOUT THE JOINT. IT WAS ALSO NOTED THAT THE PATIENT HAD EXTENSIVE FRETTING CORROSION OF THE TRUNNION OF THE FEMORAL COMPONENT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT PRODUCT(S): ITEM #103204, STEM, LOT #880720, ITEM #139254, TAPER, LOT #823380, ITEM #157442, FEMORAL HEAD, LOT #206990. REPORT SOURCE: LEGAL NOTIFICATION. MULTIPLE REPORTS HAVE BEEN SUBMITTED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-02288, 0001825034-2018-02290, 0001825034-2018-02291.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THE SHELL IS NOT RELATED TO THE EVENT; THE EVENT IS BEING REPORTED ON A DIFFERENT DEVICE ON 0001825034-2018-02290. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 7.5 YEARS POST IMPLANTATION DUE TO PAIN AND TRUNNIONOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239094 M2A-MAGNUM PF CUP 48ODX42ID HIP PROSTHESIS KWA ZIMMER BIOMET, INC. N/A 605110

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R