BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER FEM HD 32/-3MM T1

    MDR report key: 15770120 · Received November 10, 2022

    Report

    Report Number
    3002806535-2022-00462
    Event Type
    Injury
    Date Received
    November 10, 2022
    Date of Event
    September 13, 2022
    Report Date
    December 19, 2022
    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). CONCOMITANT 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. FOREIGN SOURCE: THE NETHERLANDS. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR THE INVESTIGATION AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. DEVICE IS USED FOR TREATMENT. MEDICAL RECORDS WERE NOT PROVIDED. PROVIDED RECORDS WERE REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: AN INITIAL RIGHT THA WAS PERFORMED WITH NO COMPLICATIONS NOTED. TWO DISLOCATIONS AND BOTH CORRECTED WITH CLOSED REDUCTION. IT WAS NOTED THE PATIENT EXPERIENCED PAIN AND DIFFICULTY WITH ADL'S. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: RIGHT TOTAL HIP ARTHROPLASTY WITH CEMENT FIXATION OF THE ACETABULAR CUP STATUS POST SUPERIOR AND POSTERIOR DISLOCATION WITH SUBSEQUENT REDUCTION. 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 EXPERIENCED THE SECOND DISLOCATION APPROXIMATELY 3 WEEKS LATER WHICH WAS ALSO CORRECTED WITH A CLOSED REDUCTION. PATIENT REPORTS SEVERE PAIN, DIFFICULTY WITH ACTIVITIES OF DAILY LIVING, DIFFICULTY AMBULATING WITH WALKER AND HAS A LIMP WITH A DECREASE IN RANGE OF MOTION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    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
    461201 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 Hospitalization| R SEE H10 NARRATIVE