BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UKNOWN HIP INSTRUMENT - PLANER

    MDR report key: 22570534 · Received July 22, 2025

    Report

    Report Number
    1038671-2025-02558
    Event Type
    Injury
    Date Received
    July 22, 2025
    Report Date
    August 18, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: UNKNOWN DATE IN 2021. D10: ALTEON HA COLLARED STEM SIZE: 5. ALTEON CUP, CLUSTER-HOLE 50MM. ALTEON NEUTRAL LINER. BIOLOX DELTA FEMORAL HEAD, 12/14 TAPER 36MM. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/TECHNIQUE. A REVIEW OF MANUFACTURING DATA WAS UNABLE TO BE PERFORMED AS THE LOT INFORMATION OF THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H6 UPON RECEIPT OF ADDITIONAL INFORMATION PERTAINING TO THIS EVENT, IT WAS DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. AS A RESULT, THIS COMPLAINT EVENT IS NO LONGER CONSIDERED REPORTABLE BY EXACTECH AND THIS REPORT MAY BE DISREGARDED.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A HIP CLINICAL STUDY A PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY APPROXIMATELY 4 YEARS AGO. INTRAOPERATIVELY IT WAS NOTED THAT THE PLANER HIP INSTRUMENT CREATED A SMALL POSTERIOR NECK DIVOT. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED. NO SURGICAL DELAY OR PROLONGATION WAS REPORTED. IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY HEALTH IMPACT FROM THIS EVENT. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768139 UKNOWN HIP INSTRUMENT - PLANER PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Other SEE H11.