BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOLOX DELTA CER LNR 36MM E

    MDR report key: 21718497 · Received March 28, 2025

    Report

    Report Number
    3002806535-2025-00131
    Event Type
    Malfunction
    Date Received
    March 28, 2025
    Date of Event
    February 21, 2025
    Report Date
    July 25, 2025
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    UDI-DI
    00887868271144
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO 889024519848. D10: 010000663, G7 PPS LTD ACET SHELL 52E, LOT: 7715988. G2: FOREIGN ¿ CHINA. 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. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. 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. . PRODUCT WAS RETURNED AND VISUALLY ASSESSED. THE LINER WAS RETURNED SEATED CORRECTLY IN THE SHELL AND IT WAS REMOVED FROM THE SHELL TO CONFIRM THE CORRECT ETCHING FOR SIZE 36/44 E ETCH. THE LINER APPEARED FULLY SEATED WITHIN SHELL PRIOR TO REMOVAL AND REQUIRED FORCE APPLIED TO THE POST OF LINER TO ENABLE ITS REMOVAL FROM THE SHELL. THE LINER HAS METALLIC MARKS TO THE TOP FLAT SURFACE, POST, AND OUTSIDE SURFACES. NO OTHER DAMAGE WAS NOTED DURING VISUAL EVALUATION. THE REFERENCE DIMENSIONS OF OUTER DIAMETER AND OVERALL HEIGHT OF THE LINER WERE MEASURED WHICH CONFIRMS THAT THE PRODUCT IS CORRECT TO THE ETCHING. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CANNOT BE CONFIRMED. 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 DURING SURGERY, THE CERAMIC LINER COULD NOT BE FULLY INSERTED INTO THE CUP AFTER MULTIPLE ATTEMPTS, WHICH RESULTED IN LOOSENING OF THE CUP. THE SURGEON SUSPECTED THAT THE CUP DID NOT MATCH THE LINER. A NEW LINER AND CUP WERE USED TO COMPLETE THE PROCEDURE WITH TWENTY MINUTES DELAY. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2624389 BIOLOX DELTA CER LNR 36MM E HIP PROTHESIS LPH BIOMET UK LTD. 3193955 00887868271144

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11 NARRATIVE.