BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC COMPLETE MICRO PRIMARY FEMORAL POROUS AND BONEMASTER COATED STEM 5X9MM

    MDR report key: 6231134 · Received January 6, 2017

    Report

    Report Number
    0001825034-2016-05293
    Event Type
    Injury
    Date Received
    January 6, 2017
    Date of Event
    October 18, 2016
    Report Date
    April 24, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PNOT CLEARED
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. (B)(4). THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K101086.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTIONS AND ADDITIONAL INFORMATION. REVIEW OF DEVICE HISTORY RECORDS FOUND ONE UNRELATED DEVIATION DURING THE MANUFACTURING PROCESS. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. ALL COMPONENTS WERE FOUND COMPATIBLE. NO OTHER COMPLAINTS WERE FOUND FOR THIS PART NUMBER. NO MEDICAL RECORDS WERE RECEIVED. X-RAYS WERE RECEIVED AND ANALYZED. ENTHESOPATHY IS PRESENT IN BILATERAL GREATER TROCHANTERS ASSOCIATED WITH CORTICAL IRREGULARITY AND THERE IS SOME SCLEROSIS. NO DEFINITE RIGHT GREATER TROCHANTER FRACTURE IS DIAGNOSED ON THE IMAGES SUBMITTED. FRACTURE MAY BE LESS CONSPICUOUS IN THE SETTING OF ENTHESOPATHY. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. IF ANY FURTHER INFORMATION IS FOUND THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CONCOMITANT PRODUCTS: PN# 010000702 LN# 3714125, PN# 110003621 LN# 3685887, PN# 650-1163 LN# 2015100341.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING TOTAL HIP ARTHROPLASTY, REVIEW OF POST-OPERATIVE RADIOGRAPHS REVEALED THE PATIENT'S GREATER TROCANTER WAS FRACTURED. THE FRACTURE WAS NOTED TO HAVE LIKELY OCCURRED INTRA-OPERATIVELY WITHOUT BEING DISCOVERED. THE EVENT WAS NOTED TO RESOLVE THROUGH NON SURGICAL MEANS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11767 TAPERLOC COMPLETE MICRO PRIMARY FEMORAL POROUS AND BONEMASTER COATED STEM 5X9MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 3760855

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other