BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER FM HD 032/-4.0 12/14

    MDR report key: 17331399 · Received July 17, 2023

    Report

    Report Number
    3002806535-2023-00242
    Event Type
    Injury
    Date Received
    July 17, 2023
    Date of Event
    August 18, 2011
    Report Date
    August 30, 2023
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    05019279116898
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. D10 - EXCEED ABT 3HL SHELL 39/50MM, ITEM #123950, LOT #126207. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2023-00240-1, 3002806535-2023-00243-1. 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). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2023-00240-2, 3002806535-2023-00243-2. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. NO PRODUCTS WERE RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. DEVICES ARE USED FOR TREATMENT. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. AP LEFT HIP IMAGE DEMONSTRATES A LEFT HIP DISLOCATION. AP PELVIS 2 WEEKS POST-OP DEMONSTRATES INTERVAL REDUCTION WITH ANATOMIC ALIGNMENT OF THE LEFT HIP ARTHROPLASTY. LEFT HIP ARTHROPLASTY DISLOCATION POST-OPERATIVELY WITH SUBSEQUENT REDUCTION AND ANATOMIC ALIGNMENT ON THE 2 WEEK IMAGE. INITIAL POST-OP IMAGE DEMONSTRATES A LEFT HIP ARTHROPLASTY DISLOCATION WITH NORMAL IMPLANT FIT. SUBSEQUENT 2 WEEK IMAGE SHOWS INTERVAL DISLOCATION REDUCTION AND ANATOMIC ALIGNMENT. BONE QUALITY IS OSTEOPENIC. IMPLANT POSITION AND ANATOMY APPEAR UNREMARKABLE. THE LEFT HIP ACETABULAR ANGLE MEASURES APPROXIMATELY 43 DEGREES, WITHIN THE NORMAL RANGE. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). FOREIGN - AUSTRIA. BIOLOX DELTA LNR 32MM 50-52MM; ITEM# 650-0791; LOT# UNKNOWN; MICRO TAPERLC LAT PC 9MM 12/14; ITEM# 650-0973; LOT# UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535 -2023 -00240; 3002806535 -2023 -00243. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A CLINICAL STUDY THAT A PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY APPROXIMATELY TWELVE (12) YEARS AGO. THE NEXT DAY, THE PATIENT EXPERIENCED A SPONTANEOUS SUPINE DISLOCATION. THE HIP WAS REDUCED UNDER ANESTHESIA, AND THE PATIENT HAS HAD NO COMPLICATIONS OR DISLOCATION RECURRENCE SINCE. THE PATIENT REMAINS VERY MOBILE AND SATISFIED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A CLINICAL STUDY THAT A PATIENT UNDERWENT IMPLANTATION WITH HIP PROSTHESES APPROXIMATELY TWELVE (12) YEARS AGO. POSTOPERATIVELY, ONE (1) DAY AFTER IMPLANTATION, PATIENT HAS EXPERIENCED HIP LUXATION. THE INJURY WAS TREATED BY REPOSITIONING UNDER ANESTHESIA. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1617021 DELTA CER FM HD 032/-4.0 12/14 CERAMIC FEMORAL HEAD PROSTHESIS LZO BIOMET UK LTD. N/A 2390382 05019279116898

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Hospitalization| R H10 SEE COMMENT.| SEE H10 NARRATIVE.