BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASUL, ALPHA INSERT, LL/36

    MDR report key: 22509996 · Received July 15, 2025

    Report

    Report Number
    0009613350-2025-00596
    Event Type
    Injury
    Date Received
    July 15, 2025
    Date of Event
    June 9, 2025
    Report Date
    October 31, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    UDI-DI
    00889024413658
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10. UNKNOWN SHELL ITEM# UNKNOWN LOT# UNKNOWN. UNKNOWN HEAD ITEM# UNKNOWN LOT# UNKNOWN. UNKNOWN STEM ITEM# UNKNOWN LOT# UNKNOWN. G2. REPORT SOURCE: GERMANY. 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 FOLLOWING SECTIONS WERE UPDATED: A2, A4, B3, B4, B5, B7, D1, D4, D6B, D10, G3, G6, H2, H4, H6, H10, H11. D10. ALLOFIT ALLOCLASSIC, SHELL WITH POLAR SCREW PLUG, UNCEMENTED, 58/LL ITEM# 4248 LOT# 3230118. DELTA CER FM HD 036/+4MM 12/14 ITEM# 650-0838 LOT# 3231317. MICRO TAPRLC LAT PC 17.5 12/14 ITEM# 650-0979 LOT# 7743997.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D9, G3, G6, H2, H3, H6, H10, H11. COMPLAINT CAN BE CONFIRMED THROUGH THE RETURNED PRODUCT ANALYSIS. THE HEAD AND SHELL INDICATE CONTACT FOLLOWING LINER DISASSOCIATION. THE LINER ITSELF SHOWS SIGNS CONSISTENT WITH ISSUES DURING IMPLANTATION, INCLUDING EVIDENCE SUGGESTIVE OF INCOMPLETE SEATING. THE CERAMIC HEAD, THE PE LINER AND THE METAL CUP (TOGETHER WITH THE POLE PLUG) WERE RETURNED FOR INVESTIGATION. THE TAPER OF THE CERAMIC HEAD SHOWS THE TYPICAL SEATING PATTERN FROM THE STEM. THE BEVEL OF THE HEAD DISPLAYS SCRATCHES. THE ARTICULATING SURFACE OF THE HEAD SHOWS TWO AREAS OF HEAVY METAL SMEARING. THE RIM OF THE PE LINER SHOWS SCRATCHES AND NICKS. THE ARTICULATING SURFACE IS OVERALL INCONSPICUOUS. THE BACKSIDE EXHIBITS MULTIPLE RADIAL SCRATCHES EXTENDING FROM THE CENTER TOWARD THE EDGE. ONE SIDE ALSO SHOWS LOCALIZED AREAS WITH VISIBLE SIGNS OF WEAR. THE TIP OF THE PEG WAS CUT OFF. THE COMMONLY OBSERVED INDENTATIONS LEFT ON THE LINER FROM THE TWO SPIKES OF THE CUP ARE NOT VISIBLE. THE INNER SURFACE OF THE CUP SHOWS SCRATCHES AND DENTS. ONE SIDE OF THE INNER AREA SHOWS A POLISHED AREA THAT COULD MATCH WITH THE METAL SMEARING FOUND ON THE ARTICULATING SIDE OF THE HEAD. THE ANCHORING SIDE OF THE CUP SHOWS SOME DAMAGED AND DEFORMED FIN, WITH LITTLE TO NO SIGN OF BONE GROWTH. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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 AN INITIAL SURGERY. SUBSEQUENTLY, 5 DAYS POST IMPLANTATION, UNDERWENT A REVISION SURGERY DUE TO DISASSOCIATION. DUE DILIGENCE IS IN PROCESS AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY WITH DIFFICULT INLAY PLACEMENT NOTED PREVIOUSLY. SUBSEQUENTLY, THE INLAY DISLOCATED APPROXIMATELY 5 DAYS POST-OPERATIVELY AND A COMPLETE REVISION OF THE SOCKET AND HEAD OCCURRED. NO COMPLICATIONS OCCURRED. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY AND SUBSEQUENTLY REQUIRED REVISION DUE TO INLAY DISLOCATION APPROXIMATELY 5 DAYS POST-IMPLANTATION. DURING THE INITIAL PROCEDURE, THERE WERE INTRAOPERATIVE DIFFICULTIES INSERTING THE INLAY CORRECTLY, NECESSITATING USE OF A SECOND INLAY DURING THE SAME OPERATION. APPROXIMATELY 5 DAYS POST-OPERATIVELY, THE INLAY DISLOCATED. A COMPLETE REVISION OF THE SOCKET AND HEAD WAS PERFORMED SHORTLY THEREAFTER. NO ENVIRONMENTAL FACTORS WERE REPORTED. THE PATIENT OUTCOME WAS REVISION WITH NO KNOWN COMPLICATIONS REPORTED FOLLOWING THE PROCEDURE. THE FINAL CONDITION OF THE PATIENT WAS NOT PROVIDED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153885 DURASUL, ALPHA INSERT, LL/36 PROSTHESIS, HIP LZO ZIMMER GMBH 3226932 00889024413658

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Hospitalization| R