BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA CERAMIC TAPER LINER, SIZE II / 36 I.D.

    MDR report key: 22800608 · Received August 13, 2025

    Report

    Report Number
    0009613350-2025-00649
    Event Type
    Injury
    Date Received
    August 13, 2025
    Date of Event
    July 25, 2025
    Report Date
    January 28, 2026
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    UDI-DI
    00889024429901
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10. 52MM O.D. SIZE II POROUS UNCEMENTED WITH CLUSTER HOLES SHELL USE WITH II LINERS FOR EXPORT ONLY ITEM # 65875305201 LOT # 66705730. TAPER STAND OFFSET RED NECK 10 ITEM # 00-7711-010-10 LOT # 65666052. BONE SCREW SELF-TAPPING 6.5 MM DIA. 30 MM LENGTH ITEM # 00625006530 LOT # J7658009. BONE SCREW SELF-TAPPING 6.5 MM DIA. 30 MM LENGTH ITEM # 00625006530 LOT # J7705902. BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 36/0, TAPER 12/14 ITEM # 00877503602 LOT # 3173687. G2. REPORT SOURCE: INDIA. 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 WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. A SINGLE ANTEROPOSTERIOR (AP) RADIOGRAPH OF THE HIP DEMONSTRATES A TOTAL HIP ARTHROPLASTY. THE ACETABULAR COMPONENT IS SECURED WITH TWO SCREWS. MULTIPLE RADIOPAQUE FRAGMENTS PROJECT OVER THE FEMORAL HEAD COMPONENT, CONSISTENT WITH COMPONENT FRACTURE. RADIOLUCENT LINES ARE NOTED ALONG THE SUPEROLATERAL ACETABULAR CUP AND AT THE METAL¿BONE INTERFACES OF THE SCREWS, RAISING CONCERN FOR ACETABULAR CUP LOOSENING. THE ACETABULAR CUP APPEARS TO HAVE A STEEP LATERAL ANGLE OF INCLINATION. THE PRODUCT WAS RETURNED TO THE SUPPLIER FOR ANALYSIS WHO REPORTED THAT NO PRIMARY REGULAR METAL TRANSFER CAN BE FOUND ON THE INSERT. THE LACK OF REGULAR METAL TRANSFER INDICATES INSUFFICIENT OR MISALIGNED FIXATION OF THE INSERT IN THE METAL CUP. METAL TRANSFER ON THE TRANSITION EDGE OF THE BACKSIDE TO THE TAPER AREA INDICATES A MISALIGNED POSITION OF THE INSERT IN THE METAL CUP. HOWEVER, IT CANNOT BE DETERMINED WHETHER THIS METAL TRANSFER OCCURRED PRIOR TO OR AFTER THE PRIMARY FRACTURE EVENT. METAL TRANSFER ON THE RIM OF THE INSERT INDICATES IMPINGEMENT BETWEEN THE METAL STEM AND THE CERAMIC INSERT. HOWEVER, IT CANNOT BE CONCLUSIVELY DETERMINED WHETHER THIS METAL TRANSFER OCCURRED PRIOR TO OR AFTER THE PRIMARY FRACTURE EVENT. DUE TO SECONDARY DAMAGE AND MISSING FRAGMENTS, THE PRIMARY FRACTURE SURFACE AND THE FRACTURE ORIGIN CANNOT BE IDENTIFIED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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. 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 HAD BILATERALLY HIP REPLACEMENT. AFTER APPROXIMATELY 8 MONTHS OF LEFT HIP SURGERY, STARTED GETTING PAIN IN RIGHT HIP WHICH CONTINUED TO INCREASE. AFTER CONSULTING DR, X-RAY CT SCAN WAS PERFORMED AND SHOW THAT THE PRODUCT IMPLANTED IN THE RIGHT LEG HAD DEVELOPED A CRACK. REVISION SURGERY WAS PERFORMED. CERAMIC LINER AND CERAMIC HEAD WERE REMOVED AND REPLACED BY POLY LINER AND CERAMIC HEAD. WHEN CERAMIC LINER WAS TAKEN OUT IT WAS COMPLETELY BROKEN INTO SMALL PIECES. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814309 BIOLOX DELTA CERAMIC TAPER LINER, SIZE II / 36 I.D. PROSTHESIS, HIP LZO ZIMMER GMBH 3176680 00889024429901

    Patients

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