BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACT ARTIC E1 HIP BRG 28X46MM

    MDR report key: 7335512 · Received March 13, 2018

    Report

    Report Number
    0001825034-2018-01620
    Event Type
    Injury
    Date Received
    March 13, 2018
    Date of Event
    July 28, 2014
    Report Date
    March 15, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK161190
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: 163638, 28MM COCR MOD HD +6MM NO SKIRT, 477770; US257852, MAGNUM TRISPIKE CUP 52ODX46ID, 884740. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 - 2018 - 01622. PRODUCT LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT PRODUCTS: 11-103203 TAPERLOC POR LAT FMRL 9X137. REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE PROVIDED REVISION OP NOTES. THE SURGEON ENCOUNTERED THE DISLOCATED POLYETHYLENE HEAD. IT WAS DEFORMED WHERE IT HAD BEEN SUBLUXED AND RIDING ON THE RIDGE OF THE ACETABULUM. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN THE ASSOCIATED RISK DOCUMENTATION. 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 · 1

    IT WAS REPORTED THAT THE PATIENT'S LEFT HIP HAS BEEN REVISED APPROXIMATELY THREE MONTHS POST IMPLANTATION DUE TO DISLOCATION AND SUBLUXATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEFT HIP HAS BEEN REVISED APPROXIMATELY 3 MONTHS POST IMPLANTATION DUE TO DISLOCATION AND SUBLUXATION. REVISION OP NOTES STATED "SYNOVECTOMY AND REMOVAL OF GRANULATION TISSUE WERE PERFORMED. THIS HAD THE APPEARANCE OF A POLY WEAR SOFT TISSUE ENVIRONMENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176483 ACT ARTIC E1 HIP BRG 28X46MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 663380

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R