BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA CER FEM HD 32/+3MM T1

    MDR report key: 21713741 · Received March 27, 2025

    Report

    Report Number
    3002806535-2025-00129
    Event Type
    Injury
    Date Received
    March 27, 2025
    Date of Event
    March 5, 2025
    Report Date
    September 19, 2025
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271557
    PMA / PMN Number
    K200959
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - ASSOCIATED MEDICAL DEVICES: TPRLC 133 TYPE1 BM SO 10.0; ITEM# 51-113100; LOT# 7821184 DURAL ALPHA INSERT NEUTR GG/32; ITEM # 01.00013.407; LOT # 3223772. ALLOFIT ALLOCLASSIC SHL 48/GG; ITEM # 00000004243; LOT # 3219562. G2 - FOREIGN: NETHERLANDS CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D9, G3, G6, H2, H3, H6, H11. A VISUAL REVIEW OF THE RETURNED CERAMIC HEAD CONFIRMED THAT IT HAD FRACTURED. FOUR FRACTURED PIECES WERE RECEIVED FOR EVALUATION. THE PIECES SHOW DARK MARKS IN THE TAPER HOLE AND ON THE FRACTURE SURFACES, INDICATING METAL TRANSFER. BIOLOGICAL DISCOLORATION WAS ALSO OBSERVED ON MULTIPLE PIECES. THE VISIBLE TAPER AREA SHOWS NEAR-CIRCUMFERENTIAL METAL TRANSFER, CONSISTENT WITH PROPER FIXATION OF THE HEAD. THE FRACTURE SURFACES CONTAIN METAL TRANSFER AS WELL, INDICATING THAT THE HEAD REMAINED IN VIVO AFTER THE FRACTURE OCCURRED. THIS LIKELY DAMAGED OR OBSCURED KEY FRACTURE FEATURES. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION. COMPLAINTS ARE MONITORED PER COMPLAINT TRENDING PROCESS. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. THE REVIEW IDENTIFIED THAT THE PROXIMAL FEMORAL HEAD IMPLANT IS FRACTURED AND THERE IS MILD SUBLUXATION OF THE ARTHROPLASTY SECONDARY TO THE FRACTURED FEMORAL HEAD IMPLANT, WITHOUT DISLOCATION OR OSSEOUS FRACTURE. THERE IS NO EVIDENCE OF IMPLANT LOOSENING. NO CAUSE OF THE FEMORAL HEAD IMPLANT IS IDENTIFIED. THE RETURNED CERAMIC HEAD EXHIBITED FRACTURE WITH EVIDENCE OF NEAR-CIRCUMFERENTIAL METAL TRANSFER IN THE TAPER AREA INDICATING PROPER FIXATION. HOWEVER, 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 SEVEN WEEKS AFTER IMPLANTATION, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO A FEMORAL HEAD FRACTURE. THERE WAS NO REPORTED TRAUMA, AND THE CAUSE OF THE FRACTURE REMAINS UNKNOWN. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; NO FURTHER ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2658673 BIOLOX DELTA CER FEM HD 32/+3MM T1 HIP PROSTHESIS LZO BIOMET UK LTD. 3217105 00887868271557

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H11 NARRATIVE.