BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER

    MDR report key: 7262587 · Received February 11, 2018

    Report

    Report Number
    0002648920-2018-00100
    Event Type
    Injury
    Date Received
    February 11, 2018
    Report Date
    March 30, 2018
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    PMA / PMN Number
    PK953337
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDRS WERE SUBMITTED TO REPORT THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001822565-2017-08653. THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS-00630505840 NAME: LINER STANDARD 3.5 MM OFFSET 40 MM I.D. FOR USE WITH 58 MM O.D. SHELL LOT:6 2251692.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 00801804001, VERSYS FEMORAL HEAD, LOT: 62032157, 00620205822, TRABECULAR METAL MODULAR ACETABULAR SYSTEM SHELL, LOT: 62196424 , 00785701400, VERSYS FEMORAL STEM, LOT: 61779355, 00625006530, SELF-TAPPING BONE SCREW, LOT: 62326336, 00625006530, SELF-TAPPING BONE SCREW, LOT: 62318805, 00785901300, DISTAL CENTRALIZER, LOT: 61834123. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. 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 FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    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 THAT A BILATERAL PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY AND IS EXPERIENCING PAIN AND A POPPING FEELING/NOISE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105909 FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER HIP PROSTHESIS LPH ZIMMER MANUFACTURING B.V. N/A 62032157

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R