BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVACIT-E DM BEARING

    MDR report key: 10460647 · Received August 27, 2020

    Report

    Report Number
    0001822565-2020-03072
    Event Type
    Injury
    Date Received
    August 27, 2020
    Date of Event
    August 4, 2020
    Report Date
    October 30, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024572713
    PMA / PMN Number
    K190656
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED; UPDATED: G4; H2; H3; H6. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED NOTING SUPERIOR DISLOCATION OF THE FEMORAL COMPONENT OF A LEFT TOTAL HIP ARTHROPLASTY. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE IS 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.

    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: 650-1055 ¿ BIOLOX CERAMIC HEAD ¿ 2964312, 650-1067 ¿ BIOLOX CERAMIC SLEEVE ¿ 3031111, 110024465 ¿ DUAL MOBILITY LINER - 976770, UNKNOWN CUP ¿ UNKNOWN PART AND LOT, UNKNOWN STEM ¿ UNKNOWN PART AND LOT. CUSTOMER HAS INDICATED THAT THE PRODUCT IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR THE INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REVISION AFTER AN UNKNOWN AMOUNT OF TIME POST IMPLANTATION. APPROXIMATELY 1 WEEK LATER, THE PATIENT PRESENTED TO THE ER WITH A DISLOCATED HIP. DURING RELOCATION IT WAS NOTICED THAT THE OUTER BEARING HAD DISSOCIATED FROM THE INNER HEAD AND THE PATIENT UNDERWENT A REVISION PROCEDURE THE NEXT DAY. THE HEAD, LINER, BEARING AND SLEEVE WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925206 VIVACIT-E DM BEARING PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 64689634 00889024572713

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10.