BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 OSSEOTI 3 HOLE SHELL

    MDR report key: 8869039 · Received August 7, 2019

    Report

    Report Number
    0001825034-2019-03471
    Event Type
    Injury
    Date Received
    August 7, 2019
    Date of Event
    July 10, 2019
    Report Date
    December 12, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K140669
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). UDI # : (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 RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. A G7 OSSEOTI 3 HOLE SHELL 48MM C, PART # 110010242 FROM LOT 6398821, WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. VISUAL INSPECTION FOUND THE RIM OF THE SHELL TO BE SCRATCHED SUCH THAT SOME OF THE COLOR HAS WORN OFF. FOREIGN DEBRIS REMAINS AFFIXED TO THE POROUS COATING. THE LINER WAS REMOVED FROM THE SHELL BY PRESSING ON THE DIMPLE THROUGH THE APEX HOLE OF THE SHELL. BIO DEBRIS WAS OBSERVED BETWEEN THE SHELL AND LINER. 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 · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM #00877502802, BIOLOX® DELTA, CERAMIC FEMORAL HEAD, LOT #2971426; ITEM #110010242, G7 OSSEOTI 3 HOLE SHELL, LOT #6398821; ITEM #UNKNOWN, UNKNOWN STEM, LOT #UNKNOWN; ITEM #UNKNOWN, UNKNOWN G7 INSTRUMENTS, LOT #UNKNOWN. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-03424.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY FIVE MONTHS POST OP, THE PATIENT WAS REVISED DUE TO DISLOCATION. IT WAS ALSO REPORTED THAT THE PATIENT HAD DISLOCATED THREE TIMES BEFORE THE REVISION SURGERY AND RELOCATION WAS PERFORMED EACH TIME. DURING THE REVISION PROCEDURE, IT WAS NOTED THAT THE BIOLOX HEAD HAD DISASSOCIATED FROM THE LINER AND THE LINER WAS LODGED POSTERIORLY OUTSIDE OF THE CUP. THE HEAD, LINER AND CUP WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662865 G7 OSSEOTI 3 HOLE SHELL PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 6398821

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R