BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA MODULAR CERAMIC FEM HD 32/0MM T1

    MDR report key: 19508801 · Received June 11, 2024

    Report

    Report Number
    3002806535-2024-00214
    Event Type
    Injury
    Date Received
    June 11, 2024
    Date of Event
    May 20, 2024
    Report Date
    July 17, 2024
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271564
    PMA / PMN Number
    K192683
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN: NEW ZEALAND. D10: 192010, ECHO POR FMRL NC 10X130MM, LOT #: 200860. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PICTURE RECEIVED SHOW THAT THE EXPLANT WITH THE STEM AND THE HEAD THAT HAVE BEEN REMOVED FROM THE PATIENT. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. A REVIEW OF THE RAW MATERIAL CERTIFICATE CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. MEDICAL RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. THE REVIEW IDENTIFIED TWO VIEWS OF THE RIGHT HIP DEMONSTRATE A RIGHT TOTAL HIP ARTHROPLASTY WITH POSSIBLE CEMENT FIXATION OF THE ACETABULAR CUP OR CEMENTLESS FIXATION. SUBSIDENCE OF THE FEMORAL COMPONENT IS NOTED ON THE SECOND IMAGE WITHOUT SURGICAL SKIN STAPLES. ON THE SECOND IMAGE, THERE IS ABUTMENT OF THE GREATER TROCHANTER AND THE ACETABULAR CUP AS A RESULT OF THE SUBSIDENCE. NORMAL BONE QUALITY. NO CONTRIBUTE FACTORS ARE IDENTIFIED. NO OTHER FAILURES ARE SEEN. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT 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 APPROXIMATELY TEN DAYS POST IMPLANTATION OF A TOTAL HIP ARTHROPLASTY, THE PATIENT FELL. AFTER THE FALL, THE PATIENT HAD PAIN, AND AN X-RAY SHOWED THAT THE FEMORAL IMPLANT HAD SUBSIDED. THE PATIENT¿S PAIN REPORTEDLY DID NOT RESOLVE, SO THE PATIENT HAD A REVISION SURGERY TWO MONTHS LATER. THE STEM AND HEAD WERE EXPLANTED, AND THE CUP AND LINER WERE RETAINED. NO ADDITIONAL INFORMATION AVAILABLE.

    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
    813837 BIOLOX DELTA MODULAR CERAMIC FEM HD 32/0MM T1 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LZO BIOMET UK LTD. N/A 3168215 00887868271564

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H