BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER FEM HD 32/-3MM T1

    MDR report key: 16830905 · Received April 28, 2023

    Report

    Report Number
    3002806535-2023-00126
    Event Type
    Injury
    Date Received
    April 28, 2023
    Date of Event
    November 22, 2022
    Report Date
    April 28, 2023
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271571
    PMA / PMN Number
    K192683
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - MEDICAL DEVICES: G7 VIT E NEUTRAL LNR 32MM E; ITEM# 30103205; LOT# 65224183. G7 PPS LTD ACET SHELL 52E; ITEM# 010000663; LOT# 7289876. TPRLC 133 FP TYPE1 PPS SO 7.0; ITEM# 51-100070; LOT# 7240457. G2 - FOREIGN: THE NETHERLANDS. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. 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. CONTRIBUTING FACTORS OF EVENT: PAIN, DIFFICULT WITH ADL¿S, DECREASED ROM, MULTIPLE DISLOCATIONS, RIGHT HIP REVISION DUE TO MULTIPLE DISLOCATION. 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

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DISLOCATION APPROXIMATELY 15 DAYS POST RIGHT TOTAL HIP ARTHROPLASTY AND WAS CORRECTED WITH A CLOSED REDUCTION. SUBSEQUENTLY, THE PATIENT EXPERIENCES THE SECOND DISLOCATION APPROXIMATELY 3 WEEKS LATER WHICH WAS ALSO CORRECTED WITH A CLOSED REDUCTION. SUBSEQUENTLY, A REVISION SURGERY WAS PERFORMED APPROXIMATELY A MONTH LATER DUE TO RECURRING DISLOCATIONS. PATIENT REPORTS SEVERE PAIN, DIFFICULTY WITH ACTIVITIES OF DAILY LIVING, DIFFICULTY AMBULATING WITH WALKER AND HAS A LIMP AND DECREASED RANGE OF MOTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1235822 DELTA CER FEM HD 32/-3MM T1 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LZO BIOMET UK LTD. N/A 3115034 00887868271571

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H