BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RECAP HIP SYSTEMS

    MDR report key: 2904845 · Received January 9, 2013

    Report

    Report Number
    0001825034-2013-00081
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    December 18, 2012
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KXA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2013 INDICATING THAT ALL PRODUCT REFERENCED IN THIS MDR SUBMISSION WAS ACTUALLY MANUFACTURED BY THE BIOMET (B)(4) FACILITY INSTEAD OF THE BIOMET US, (B)(4) ORTHOPEDICS FACILITY. ALL FIELDS RELATING TO MANUFACTURER AND CONTACT INFORMATION HAVE BEEN CHANGED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION BEING REPORTED WAS FOUND IN A JOURNAL ARTICLE TITLED "HIP RESURFACING IN A DISTRICT GENERAL HOSPITAL: 6-YEAR CLINICAL RESULTS USING THE RECAP HIP RESURFACING SYSTEM". BMC MUSCULOSKELETAL DISORDERS 2012, 13:247 DOI:10.1186/1471-2474-13-247. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENTS. EVENT DETAILS AND PRODUCT IDENTIFICATION WAS NOT PROVIDED FOR THE REVISIONS MENTIONED IN THE JOURNAL ARTICLE, THEREFORE, THE FOLLOWING SECTIONS COULD NOT BE COMPLETED: DATE OF EVENTS- UNKNOWN, EXPIRATION DATES - UNKNOWN, DATES IMPLANTED - UNKNOWN, DATES EXPLANTED - UNKNOWN. INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY WALTER VAN DER WEEGEN, HENK J HOEKSTRA, THEA SIJBESMA, SHENNAH AUSTEN AND RUDOLF W POOLMAN, MANUFACTURE DATES - UNKNOWN. IT IS LIKELY THAT THESE COMPLICATIONS AND REVISIONS HAVE ALREADY BEEN REPORTED; HOWEVER, IT CANNOT BE DETERMINED BASED ON THE LIMITED INFORMATION MADE AVAILABLE IN THE ARTICLE. SHOULD ADDITIONAL INFORMATION RELATING TO THE EVENTS BE RECEIVED, THE UPDATED INFORMATION WILL BE FORWARDED TO THE FDA.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICAL IN WHICH CLINICAL RESULTS OF (280) TWO-HUNDRED EIGHTY HIP REPLACEMENTS (240 PATIENTS) WHO RECEIVED A RECAP RESURFACING SYSTEM. SIXTEEN REVISIONS WERE REPORTED: SEVEN FOR FRACTURE OF FEMORAL NECK. ONE FOR MALPOSITIONED FEMORAL COMPONENT. ONE FOR MALPOSITIONED ACETABULAR COMPONENT. FIVE FOR ASEPTIC LOOSENING. TWO FOR PERSISTANT PAIN. POSTOPERATIVE HISTOPATHOLOGICAL ANALYSES INDICATED ADVERSE LOCAL TISSUE REACTION TO METAL DEBRIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12933 UNKNOWN RECAP HIP SYSTEMS PROSTHESIS, HIP KXA BIOMET UK LTD. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R