BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA LNR 36MM 62-70MM

    MDR report key: 20993469 · Received December 20, 2024

    Report

    Report Number
    3002806535-2024-00478
    Event Type
    Injury
    Date Received
    December 20, 2024
    Date of Event
    November 21, 2024
    Report Date
    July 18, 2025
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - ASSOCIATED MEDICAL DEVICES: DELTA CERAMIC FEM HD 36/+3MM; ITEM# 650-0662; LOT# 3172876. TAPERLOC BM/PC LAT 15.0X150 T1 M T1; ITEM# 11-103208BM; LOT# 6960025. EXC ABT STD SHELL HA/PC 062MM M; ITEM# 125262HA; LOT# 3374329. G2 - FOREIGN: UNITED KINGDOM. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D4, D9, G1-2, G3, G4, G6, H2, H3, H6, H11. THE FOLLOWING SECTIONS WERE CORRECTED: G1-2. D4 - THIS PRODUCT IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). G4 - THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K190660. AN UNBROKEN CERAMIC FEMORAL HEAD, ONE LARGE, FOUR SMALL AND ELEVEN VERY SMALL FRAGMENTS OF A CERAMIC LINER WERE RETURNED TO THE MANUFACTURER, CERAMTEC, FOR INVESTIGATION AND IS SUMMARISED BELOW. THE INVESTIGATION IDENTIFIED THAT THE DENSITY OF THE LINER COMPLIES WITH THE MATERIAL SPECIFICATION. THE MICROSTRUCTURE MEETS THE REQUIREMENTS SPECIFIED AT THE TIME OF PRODUCTION AND THERE IS NO INDICATION OF ANY PRE-EXISTING MATERIAL DEFECT. UNEQUALLY DISTRIBUTED PRIMARY METAL TRANSFER ON THE CERAMIC HEAD TAPER INDICATES THAT THE INTERFACE HAD BEEN DISTURBED DURING THE ASSEMBLY OF THE HEAD AND METAL FEMORAL STEM TAPER. IN ADDITION, NO PRIMARY REGULAR METAL TRANSFER CAN BE FOUND ON THE LINER. THIS COULD INDICATE INSUFFICIENT OR MISALIGNED FIXATION OF THE CERAMIC LINER IN THE METAL CUP. FURTHER, DUE TO SECONDARY DAMAGE AND MISSING FRAGMENTS, THE PRIMARY FRACTURE SURFACE OF THE LINER AND THE FRACTURE ORIGIN CANNOT BE IDENTIFIED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS OF THE CERAMIC LINER 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. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, A POTENTIALLY MISALIGNED POSITION OF THE LINER MAY HAVE RESULTED IN LOCALIZED INCREASES IN MECHANICAL STRESS, WHICH APPEARS TO BE THE MOST PLAUSIBLE CONTRIBUTING FACTOR TO THE LINER FRACTURE. 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 7 WEEKS POST IMPLANTATION, THE PATIENT UNDERWENT A REVISION DUE TO CERAMIC HIP LINER FRACTURE. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; NO FURTHER ADDITIONAL INFORMATION 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
    2376821 BIOLOX DELTA LNR 36MM 62-70MM HIP PROSTHESIS LZO BIOMET UK LTD. 3033480

    Patients

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