BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 TYPE1 PPS SO 10.0

    MDR report key: 7374634 · Received March 27, 2018

    Report

    Report Number
    0001825034-2018-02093
    Event Type
    Injury
    Date Received
    March 27, 2018
    Date of Event
    June 30, 2017
    Report Date
    November 15, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK101086
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. A TAPERLOC STEM WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. THE STEM IS IN PRISTINE CONDITION. NO DAMAGE WAS FOUND ON THE NECK, POROUS COATING, OR DISTAL END OF THE STEM. ONLY A FEW NICKS AND DINGS WERE OBSERVED NEAR THE ETCHING ON THE TOP OF THE TAPER. A SMALL AMOUNT OF FOREIGN MATERIAL WAS STILL AFFIXED WITHIN THE POROUS COATING. DIMENSIONAL ANALYSIS WAS CONFORMING TO SPECIFICATIONS. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4) PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM # 11-363660, FEMORAL HEAD, LOT # 752950. ITEM # 51-103090, FEMORAL STEM, LOT # 3971799. ITEM # 00625006525, BONE SCREW, LOT # 63651669. ITEM # 00875101036, LINER, LOT # 63624627. ITEM # 00875705201, CUP, LOT # 63465370.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN INITIAL RIGHT TOTAL HIP PROCEDURE THAT THE STEM WOULD NOT SEAT PROPERLY AFTER ROUTINE BROACH TECHNIQUE WAS PERFORMED. THE FEMUR WAS BROACHED TO 10 MM AND THE 10 MM STEM INSERTED UNSUCCESSFULLY. THE FEMUR WAS THEN BROACHED 8 MORE TIMES TO 10 MM, AND THEN BROACHED TO 11 MM. THE 10 MM STEM CONTINUED TO NOT SEAT PROPERLY. A 9 MM STEM WAS OPENED AND WAS INSERTED SUCCESSFULLY. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218992 TPRLC 133 TYPE1 PPS SO 10.0 HIP PROSTHESIS KWA ZIMMER BIOMET, INC. N/A 3809732

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| O