BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR HD LNG NK 32 +4MM 12/14

    MDR report key: 9863708 · Received March 22, 2020

    Report

    Report Number
    3002806535-2020-00178
    Event Type
    Injury
    Date Received
    March 22, 2020
    Date of Event
    November 16, 2018
    Report Date
    August 26, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G4, G7, H1, H2, H10. G3: REPORT SOURCE, FOREIGN - EVENT OCCURRED IN TURKEY. CORRECTION: UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED AN MDR SHOULD NOT HAVE BEEN FILED UNDER THE CURRENT MANUFACTURER. ANY FOLLOW-UPS RELATED TO THIS EVENT WILL BE REPORTED BY MEDWATCH FACILITY FRANCE BIOMET - 3006946279.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY AT THE PRIVATE (B)(6) HOSPITAL, TURKEY. SUBSEQUENTLY, THE PATIENT HAS REPORTED THAT A DISLOCATION TOOK PLACE ON (B)(6) 2018 WHERE HE WAS TREATED AT THE SAME HOSPITAL. A FURTHER DISLOCATION TOOK PLACE AND THE PATIENT WAS REVISED ON (B)(6) 2018, AGAIN AT THE SAME HOSPITAL. NO FURTHER INFORMATION HAS BEEN PROVIDED. THIS COMPLAINT REPORTS THE REVISION SURGERY PERFORMED ON (B)(6) 2018.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). THE PRODUCT HAS BEEN RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. MEDICAL PRODUCT: RINGLOC-X E1 10DEG 52/32MM, CATALOG #: EP-063252, LOT #: 6002209; MEDICAL PRODUCT: EXC ABT RNGLC-X SHELL PC 052MM, CATALOG #: 131352, LOT #: 3972375; MEDICAL PRODUCT: UNKNOWN SCREW, CATALOG #: UNKNOWN SCREW, LOT #: UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2020-00177. OCCUPATION: PATIENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY AT THE (B)(6) HOSPITAL, (B)(6). SUBSEQUENTLY, THE PATIENT HAS REPORTED THAT A DISLOCATION TOOK PLACE ON (B)(6) 2018 WHERE HE WAS TREATED AT THE SAME HOSPITAL. A FURTHER DISLOCATION TOOK PLACE AND THE PATIENT WAS REVISED ON (B)(6) 2018, AGAIN AT THE SAME HOSPITAL. NO FURTHER INFORMATION HAS BEEN PROVIDED. THIS COMPLAINT REPORTS THE REVISION SURGERY PERFORMED ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327152 COCR HD LNG NK 32 +4MM 12/14 HIP ARTHROPLASTY JDI BIOMET UK LTD. N/A J3729833

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEEH10