BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHELL 45 MM O.D.

    MDR report key: 15267093 · Received August 22, 2022

    Report

    Report Number
    0002648920-2022-00178
    Event Type
    Injury
    Date Received
    August 22, 2022
    Date of Event
    July 18, 2022
    Report Date
    September 13, 2022
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    KWY
    UDI-DI
    00889024115330
    PMA / PMN Number
    K833991
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, AS SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 00500104428/BIPOLAR LINER 44/45/46MM OD X 28MM ID/65299025. 00877502803/BIOLOX DELTA FEM HEAD, 28MM, +3.5MM/3090897. 01.06010.001/AVENIR MLLER STEM 1 STANDARD/ 2955598.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: THE PATIENT UNDERWENT A HEMIARTHROPLASTY. DURING A FOLLOW UP, THE PATIENT HAD MINIMAL PAIN WITH IMAGING DONE, WHERE THE PELVIS WAS NOTED TO BE WELL POSITIONED AND APPROPRIATE LENGTH. IF DISLOCATIONS OCCURRED, A REVISION WOULD BE CONSIDERED. SINCE THE FOLLOW UP, THE PATIENT EXPERIENCED REOCCURRING DISLOCATIONS AND UNDERWENT A REVISION. LAXITY OF SOFT TISSUES WAS FOUND AND SCAR TISSUE DEBRIDED. THE SHELL, LINER, AND HEAD WERE REMOVED AND REPLACED WITH TOTAL HIP ZIMMER PRODUCTS AND NO COMPLICATIONS WERE NOTED. REVIEW OF THE DEVICE HISTORY RECORDS 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

    IT WAS REPORTED A PATIENT UNDERWENT A LEFT HEMIARTHROPLATY ON. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION TO A TOTAL HIP ARTHROPLASTY DUE TO RECURRING DISLOCATIONS APPROXIMATELY 1 MONTH LATER. DURING THE PROCEDURE, MILD LAXITY WAS NOTED TO THE SOFT TISSUES AND SCAR TISSUE WAS DEBRIDED TO INCREASE INTERNAL ROTATION. ALL COMPONENTS EXCEPT THE STEM WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2310259 SHELL 45 MM O.D. PROSTHESIS, HIP KWY ZIMMER MANUFACTURING B.V. N/A 65341078 00889024115330

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H SEE H10