BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACT ARTIC E1 HIP BRG 28X44MM

    MDR report key: 10650138 · Received October 8, 2020

    Report

    Report Number
    0001825034-2020-03713
    Event Type
    Injury
    Date Received
    October 8, 2020
    Date of Event
    September 18, 2020
    Report Date
    December 9, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K101336
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: FOLLOW UP VISIT, NOTES PAIN 8/10, SWELLING, NOTES DISLOCATION EPISODE 2 WEEKS POST OP TREATED WITH A CLOSED REDUCTION. CONCERNED WITH LUCENCY NOTED AROUND CUP. X-RAYS DEMONSTRATE THE STEM MAY HAVE SUBSIDED A LITTLE BIT BUT DIFFICULT TO TELL BASED ON ORIENTATION OF X-RAY. CHRONICALLY DISLOCATED RIGHT TOTAL HIP ARTHROPLASTY, ATTEMPTED REVISION WITH CONVERSION TO GIRDLESTONE ARTHROPLASTY. SCAR TISSUE REMOVED FROM FEMORAL NECK AND HEAD. PSEUDOCAPSULE REMOVED. ATTEMPTED TO REDUCE THE TRUNNION INTO THE CUP BUT WERE EASILY 2CM OR MORE FROM ACCOMPLISHING THIS. AFTER REMOVING SCAR TISSUE FROM FEMUR AND ACETABULUM, SURGEON FELT TO REMOVE MORE TISSUE WOULD HAVE REQUIRED SKELETONIZING THE PROXIMAL FEMUR AND REMOVING ABDUCTORS WHICH HE WAS HESITANT TO DO AS IT MAY REMOVE REASONABLE FUNCTION. ILIOPSOAS WAS REMOVED ON INITIAL SURGERY, THEREFOR A GIRDLESTONE ARTHROPLASTY COMMENCED. SIGNIFICANT BLEEDING THROUGHOUT CASE AS ALL TISSUES WERE IRRITABLE AND BLEEDING COPIOUSLY. ACETABULAR COMPONENT REMAINED WELL FIXED AND LEFT IN PLACE TO AVOID FURTHER BLOOD LOSS. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT 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 DEVICES: ZIMMER CAT#00-8775-028-01 LOT# 2993959 NA BIOLOX DELTA FEM HEAD, 28MM, -3.5MM; ZIMMER CAT#00-7711-011-10 LOT#63622660 NA M/L TAPER 11 STD REDUCED NECK LENGTH; BIOMET CAT#110024464 LOT#891800 G7 DUAL MOBILITY ACETABULAR LINER. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS DUE TO THE DEVICE BEING DISCARDED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT RIGHT THA. SUBSEQUENTLY, PATIENT WAS REVISED APPROXIMATELY 7 MONTHS LATER DUE TO RECURRENT DISLOCATIONS. 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
    1113179 ACT ARTIC E1 HIP BRG 28X44MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 885430

    Patients

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