BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA LNR 40MM 58-60MM

    MDR report key: 22864473 · Received August 21, 2025

    Report

    Report Number
    3002806535-2025-00404
    Event Type
    Injury
    Date Received
    August 21, 2025
    Date of Event
    July 30, 2025
    Report Date
    December 19, 2025
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D-4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO 00889024519848. D10 ¿ 650-1058, CER BIOLOXD OPTION HD 40MM, LOT 941726. 650-1066, CER OPT TYPE 1 TPR SLEVE 0MM, LOT 2240861. 124858HA, EXC ABT STD SHELL HA/PC 058MM, LOT 2125841. 21-123207, HA TPRLOC POR LAT FML 13.5X147, LOT 185550. G2 ¿ FOREIGN ¿ AUSTRALIA. G-4: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K190660. 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 AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H3, H6, H10, H11. THE FOLLOWING SECTION WAS CORRECTED: G4 - PMA/510(K) NUMBER THE REPORTED EVENT COULD NOT BE CONFIRMED DUE TO LACK OF PRODUCT/INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE NOT PROVIDED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORIES FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THE CUP, THE STEM, THE BEARING AND THE SLEEVE ITEMS AND THE REPORTED PART AND LOT COMBINATIONS. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED HEAD ITEM AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION. 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 THE PATIENT UNDERWENT HIP REVISION SURGERY APPROXIMATELY THIRTEEN AND A HALF YEARS POST IMPLANTATION. THE PATIENT HAD AN EARLY DISLOCATION AND THEN AFTER REDUCTION, THE HIP HAS SURVIVED WITHOUT DISLOCATION UNTIL RECENTLY. AS THERE HAVE BEEN A NUMBER OF DISLOCATIONS, THE DECISION WAS MADE TO REVISE THE CUP (VERSION WAS FELT TO BE NOT OPTIMAL). ON OPENING THE HIP, BOTH COMPONENTS APPEARED WELL FIXED. THE HEAD WAS REMOVED BUT THE SLEEVE REMAINED ATTACHED TO THE FEMORAL STEEPER. THE SURGEON ATTEMPTED TO REMOVE THIS BUT FAILED AND A DECISION WAS MADE TO REMOVE THE STEM TO ALLOW FOR A NEW FREEDOM HEAD TO BE PLACED. ALL COMPONENTS WERE REMOVED. AN OSEOTI SHELL PLANTED WITH 3 SCREWS AND A FREEDOM LINER. AN ARCOS STEM WAS IMPLANTED WITH A FREEDOM HEAD. HIP APPEARED SIGNIFICANTLY MORE STABLE WHEN TESTING AT THE END OF THE PROCEDURE. NO ADDITIONAL INFORMATION IS 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
    418865 BIOLOX DELTA LNR 40MM 58-60MM HIP PROTHESIS LPH BIOMET UK LTD. 2063944

    Patients

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