BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC COMPLETE MICRO PRIMARY FEMORAL

    MDR report key: 7269478 · Received February 14, 2018

    Report

    Report Number
    0001825034-2018-00879
    Event Type
    Injury
    Date Received
    February 14, 2018
    Date of Event
    December 9, 2015
    Report Date
    February 12, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK110400
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: EXCEED ABT SHELL CATALOG# 123748 LOT# 3120542, BIOLOX DELTA LINER CATALOG# 650-0790 LOT# 3283248, DELTA CERAMIC FEMORAL HEAD CATALOG# 164136 LOT# 3232440, UNKNOWN SCREW CATALOG: NI LOT# NI. (B)(6). THE DEVICE WAS NOT RETURNED FOR EVALUATION DUE TO UNKNOWN LOCATION. REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND NO DEVIATIONS OR ANOMALIES, HOWEVER CONCESSIONS WERE NOTED. REVIEW OF COMPLAINT HISTORY FOR SAME OR SIMILAR ISSUE IDENTIFIED FIVE COMPLAINTS FOR PART (ITEM) NUMBER AND NO ADDITIONAL COMPLAINTS WERE IDENTIFIED FOR PART/LOT COMBINATION. WITHOUT THE OPPORTUNITY TO EVALUATE THE DEVICE, THE COMPLAINT WAS NOT CONFIRMED AND ROOT CAUSE COULD NOT BE DETERMINED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. ASSOCIATED RISK TABLE LISTS "MISCELLANEOUS USER NEEDS (GENERAL POST-OPERATIVE PAIN )¿. FOLLOWING REVIEW, NO NEW RISKS WERE IDENTIFIED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED AS PART OF A CLINICAL STUDY THAT A PATIENT UNDERWENT A LEFT HIP SURGERY ON (B)(6) 2015. SUBSEQUENTLY, THE PATIENT REPORTED MODERATE PAIN WHICH IS TOLERABLE AND REQUIRED OCCASIONAL USE OF MEDICATION STRONGER THAN ASPIRIN, SOME LIMITATIONS OF ORDINARY ACTIVITY OR WORK, AND A MODERATE LIMP REQUIRING TWO CANES FOR SUPPORT. THE PATIENT ALSO REPORTED INABILITY TO DO STAIRS, EXTREMELY DIFFICULT TO WASH/DRY, MODERATE TROUBLE GETTING IN OR OUT OF CAR, EXTREMELY DIFFICULT TO PUT ON SOCKS, MODERATELY DIFFICULT TO SHOP, ONLY ABLE TO WALK AROUND HOUSE BEFORE SEVERE PAIN, EXTREMELY DIFFICULT TO CLIMB STAIRS, VERY PAINFUL TO STAND UP, LIMPING MOST OF THE TIME, PAIN THAT GREATLY INTERFERED WITH USUAL WORK, IN BED WITH PAIN MOST NIGHTS DURING SIX MONTHS POST OP VISIT ON (B)(6) 2015. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114178 TAPERLOC COMPLETE MICRO PRIMARY FEMORAL PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 2745471

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other| R