BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CERAMIC FEM HD 36/+3MM

    MDR report key: 17207345 · Received June 27, 2023

    Report

    Report Number
    3002806535-2023-00210
    Event Type
    Injury
    Date Received
    June 27, 2023
    Date of Event
    December 6, 2022
    Report Date
    November 21, 2023
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271182
    PMA / PMN Number
    K192683
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED A MEDWATCH REPORT SHOULD NOT HAVE BEEN FILED BECAUSE THE EVENT IS A DUPLICATE OF A PREVIOUSLY REPORTED INCIDENT. THIS EVENT HAS PREVIOUSLY BEEN REPORTED UNDER MFR REPORT NUMBER 3002806535-2022-00512. GIVEN THIS INFORMATION, THIS MEDWATCH WILL BE VOIDED.

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - MEDICAL DEVICES: 36MM I.D. SIZE E NEUTRAL; ITEM# 30103605; LOT# 65516876. G7 PPS LTD ACET SHELL 52E; ITEM# 010000663; LOT# 7311439. TPRLC 133 T1 PPS HO 12X144MM; ITEM# 51-104120; LOT# 6992221. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THAT THE CERAMIC FEMORAL HEAD APPEARS TO BE FRACTURED IN 3 PIECES AND THERE APPEARS TO BE METAL TRANSFER ON THE INTERNAL DIAMETER SURFACE FROM THE STEM TAPER. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. DEVICE IS USED FOR TREATMENT. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. PATIENT REPORTED THAT THEY "FELT A CLUNK" WHILE REACHING FOR THE CUPBOARD, BUT REPORTED NO TRAUMA. AN EVALUATION CARRIED OUT PRIOR TO THE REVISION SHOWED WHAT APPEARED TO BE A FRACTURED CERAMIC HEAD. DURING REVISION SURGERY THE CERAMIC FEMORAL HEAD WAS REPORTED TO BE FRACTURED INTO 3 PIECES. ACETABULAR AND FEMORAL STEM COMPONENT WERE WELL ALIGNED AND WELL FIXED BUT DAMAGE TO THE LINER WAS REPORTED. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED A MEDWATCH REPORT SHOULD NOT HAVE BEEN FILED BECAUSE THE EVENT IS A DUPLICATE OF A PREVIOUSLY REPORTED INCIDENT. THIS EVENT HAS PREVIOUSLY BEEN REPORTED UNDER MFR REPORT NUMBER 3002806535-2022-00512. GIVEN THIS INFORMATION, THIS MEDWATCH WILL BE VOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, TWO WEEKS LATER THE PATIENT WAS REVISED DUE TO FRACTURED FEMORAL HEAD WITH POLY DAMAGE. THE POLY LINER AND FEMORAL HEAD WERE REVISED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    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
    1478083 DELTA CERAMIC FEM HD 36/+3MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LZO BIOMET UK LTD. N/A 3119039 00887868271182

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H