BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTRAINED HEAD

    MDR report key: 13168617 · Received January 5, 2022

    Report

    Report Number
    0001822565-2022-00023
    Event Type
    Injury
    Date Received
    January 5, 2022
    Date of Event
    November 19, 2021
    Report Date
    March 23, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    UDI-DI
    00889024499041
    PMA / PMN Number
    K183457
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT PRODUCTS: 010000980 3929945 G7 FREEDOM CONST E1 LNR 32MM B; 110010261 6952447 G7 OSSEOTI MULTIHOLE 46MM B; COMPETITOR POLAR FEMORAL COMPONENT. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO THE DEVICE WAS REQUESTED, BUT NOT RETURNED BY THE HOSPITAL. 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 - 2021 - 03272.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS RECEIVED. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED FINDINGS OF RECURRENT DISLOCATIONS. PATIENT DISLOCATED MULTIPLE TIMES POST-OP AFTER A PREVIOUS REVISION. NECROSIS, WELL-FIXED CUP, AND PREVIOUS CABLES WERE REMOVED, NO COMPLICATIONS DURING THIS REVISION. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED, HOWEVER, IT WAS NOTED A COMPETITOR STEM WAS USED WITH A ZIMMER BIOMET HEAD/LINER, AND WHILE THIS IS CONSIDERED OFF-LABEL USE IT IS UNKNOWN IF THIS CAUSED OR CONTRIBUTED TO THE EVENT. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT RIGHT HEMIARTHROPLASTY TO REPAIR A FEMORAL NECK FRACTURE. SUBSEQUENTLY 3 DISLOCATIONS OCCURRED RESULTING IN CONVERSION TO RIGHT TOTAL HIP ARTHROPLASTY APPROXIMATELY 3 MOTHS POST RIGHT HEMIARTHROPLASTY. PATIENT SUSTAINED A FALL APPROXIMATELY 6 WEEKS POST OP THAT RESULTED IN A DISLOCATION AND 2 ADDITIONAL DISLOCATIONS OCCURRED POST REDUCTION. REVISION PERFORMED APPROXIMATELY 3 MONTHS POST THA WITH REMOVAL OF HEAD/LINER, AND COMPETITOR STEM. SURGEON NOTED NECROSIS OF CAPSULE AND WELL-FIXED ACETABULUM. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1643194 CONSTRAINED HEAD PROSTHESIS, HIP KWY ZIMMER BIOMET, INC. N/A 3036163 00889024499041

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H