BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX® DELTA, CERAMIC FEMORAL HEAD, L, ø 36/+3.5, TAPER 12/14

    MDR report key: 23124397 · Received September 23, 2025

    Report

    Report Number
    0009613350-2025-00730
    Event Type
    Injury
    Date Received
    September 23, 2025
    Report Date
    March 12, 2026
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    K200112
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H3, H6, H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORIES IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM/S AND THE PART AND LOT COMBINATION. REVIEW OF THE REPORTED EVENT BY A HEALTH CARE PROFESSIONAL FOUND: PERIPHERAL NERVE INJURY OR DISEASE CAN CAUSE SYMPTOMS OF PAIN, BURNING, DYSESTHESIA, AND EITHER PARTIAL OR COMPLETE LOSS OF SENSORY AND MOTOR FUNCTION. NEURAPRAXIA, THE MILDEST GRADE OF NERVE INJURY, IS CHARACTERIZED BY A REDUCTION OR COMPLETE BLOCKAGE OF CONDUCTION ACROSS A SEGMENT OF NERVE. NEURAPRAXIA CAN RESULT FROM DIRECT MECHANICAL COMPRESSION, ISCHEMIA SECONDARY TO VASCULAR COMPROMISE, METABOLIC DERANGEMENTS, OR DISEASES OR TOXINS CAUSING DEMYELINATION OF THE NERVE. CONDUCTION IS RESTORED ONCE EITHER THE METABOLIC DERANGEMENT IS CORRECTED OR REMYELINATION OCCURS. NEURAPRAXIC INJURIES ARE USUALLY REVERSIBLE, AND A FULL RECOVERY CAN OCCUR WITHIN DAYS TO WEEKS. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4): D10: ITEM # 0100561317, WAGNER CONE PROSTHESIS®, 135°, UNCEMENTED, ø 17, TAPER 12/14, LOT # 3122141. ITEM # 30103604, 36MM I.D. SIZE D NEUTRAL LINER, LOT # 66179347. ITEM # 00625006520, BONE SCREW SELF-TAPPING 6.5 MM DIA. 20 MM LENGTH, LOT # J7488887. ITEM # 00625006525, BONE SCREW SELF-TAPPING 6.5 MM DIA. 25 MM LENGTH, LOT # J7526159. ITEM # 110010243, G7 OSSEOTI 3 HOLE SHELL 50MM D, LOT # 65862844. 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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT HIP REPLACEMENT. SUBSEQUENTLY, APPROXIMATELY 6 MONTHS POST IMPLANTATION THE PATIENT UNDERWENT SURGERY DUE TO COMPRESSED LEFT PERONEAL NERVE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148253 BIOLOX® DELTA, CERAMIC FEMORAL HEAD, L, ø 36/+3.5, TAPER 12/14 PROSTHESIS, HIP LZO ZIMMER GMBH 3156929

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R SEE H11 NARRATIVE.