BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCREW SELF-TAPPING 6.5 MM DIA. 30 MM LENGTH

    MDR report key: 21849452 · Received April 16, 2025

    Report

    Report Number
    0002648920-2025-00113
    Event Type
    Injury
    Date Received
    April 16, 2025
    Report Date
    April 16, 2025
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    PMA / PMN Number
    K934765
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). B3: EVENT OCCURRED IN JAN 2021. D10: CAT#: 110010264, LOT#: 6392037 G7 OSSEOTI MULTIHOLE 52MM E. CAT#: 010000857, LOT#: 6500064 G7 NEUTRAL E1 LINER 36MM E. CAT#: 650-1057, LOT#: 2952466 CER BIOLOXD OPTION HD 36MM. CAT#: 650-1066, LOT#: 2959111 CER OPT TYPE 1 TPR SLEVE 0MM. CAT#: 51-108080, LOT#: 6490058 TPRLC 133 MP T1 PPS SO 8X101MM. CAT#: 51-108080, LOT#: 6490058 TPRLC 133 MP T1 PPS SO 8X101MM. CAT#: 00625006530, LOT#: 64334917 BONE SCREW SELF-TAPPING 6.5 MM DIA. 30 MM LENGTH. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: PATIENT HAD A LEFT INITIAL TOTAL HIP ARTHROSCOPY APPROXIMATELY 6 YEARS AGO. SUBSEQUENTLY, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH A COMPLAINT OF MEDIAL LEFT LEG PARAESTHESIA SINCE THE INITIAL SURGERY. PATIENT HAD A SERIES OF FOLLOW-UPS REPORTING INCREASED PAIN IN LEFT HIP. THE PATIENT THEN PRESENTED WITH POST OPERATIVE QUADRICEPS NERVE PALSY. APPROXIMATELY 5 YEARS POST INITIAL TOTAL HIP ARTHROSCOPY, THE PATIENT REPORTED THAT THE NEUROLOGIST RECOMMENDED A VISIT TO A NEUROSURGEON FOR NERVE TRANSPLANT. THE PATIENT REPORTED THAT THEY HAD A FEMORAL NERVE REPAIR DUE TO NERVE PALSY BECAUSE OF A NERVE LESION DURING THE LEFT TOTAL HIP ARTHROSCOPY. APPROXIMATELY ONE YEAR LATER, THE PATIENT REPORTS NO PAIN AND AMBULATES WITH NORMAL GAIT WITHOUT ASSISTIVE DEVICES. X-RAY SHOWED THE IMPLANT IN GOOD POSITION, NO EVIDENCE OF LYSIS, FRACTURE, BEARING WEAR, OR SUBSIDENCE. NO DEVICES WERE EXPLANTED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. HOWEVER, THE SURGICAL TECHNIQUE WAS THOUGHT TO BE A POTENTIAL FACTOR THAT COULD HAVE CONTRIBUTED TO THE NERVE LESION. AS PER INSTRUCTIONS FOR USE IT STATES UNDER RISKS, "WHILE COMPLICATIONS VARY DEPENDING ON THE TYPE OF ORTHOPAEDIC SURGERY AND WHILE MITIGATION'S ARE IMPLEMENTED TO REDUCE THESE RISKS AS FAR AS POSSIBLE, SOME RESIDUAL RISKS, ASSOCIATED WITH THE SYSTEM, INCLUDING ITS COMPONENTS, CAN ARISE DURING AND FOLLOWING SURGERY INCLUDE PAIN OR ACHE, TISSUE DAMAGE. BASED ON THE PROVIDED INFORMATION, THE COMPLAINT CANNOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT UNDERWENT A FEMORAL NERVE REPAIR DUE TO A NERVE LESION APPROXIMATELY A YEAR AND EIGHT MONTHS POST IMPLANTATION OF A LEFT TOTAL HIP ARTHROSCOPY. ALL OF THE IMPLANTS REMAIN IN PLACE AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. 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
    122578 BONE SCREW SELF-TAPPING 6.5 MM DIA. 30 MM LENGTH PROTHESIS, HIP LPH ZIMMER MANUFACTURING B.V. 64334916

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H