BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LOW PROFILE SCREW 6.5X25MM

    MDR report key: 7112464 · Received December 13, 2017

    Report

    Report Number
    0001825034-2017-11129
    Event Type
    Injury
    Date Received
    December 13, 2017
    Date of Event
    April 22, 2016
    Report Date
    December 18, 2017
    Manufacturer
    BIOMET ORTHOPEDICS LLC
    Product Code
    LPH
    PMA / PMN Number
    PK991807
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING REPORT IS SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: BI-METRIC POROUS FMRL 10X130MM LOT#4:13490, ITEM#:162252, 36 MM MODULAR HEAD LOT#:653530, ITEM#11-363662, MAX-MOM(TW) RINGLOC (R) 35 MM ACETABULAR LINER SIZE 23/PLUS 5 MM, LOT#:224870 ITEM#: XL-155233, M/H RADIAL 3-HOLE SHELL 62MM LOT#:403020, ITEM#:12-104162. THE REPORTED EVENT IS CONFIRMED. THE REPORTED COMPONENTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. NO PRODUCTS WERE RETURNED; THEREFORE, THE VISUAL AND DIMENSIONAL INSPECTIONS WERE NOT PERFORMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THE REPORTED COMPONENTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. REVIEW OF REVISION OPERATIVE NOTES DATED (B)(6) 2016 STATE THAT THE PATIENT UNDERWENT REVISION OF LEFT TOTAL HIP ARTHROPLASTY WITH REPLACEMENT OF THE ACETABULAR COMPONENT AND THE FEMORAL HEAD. A BONE SCAN WAS OBTAINED WHICH DEMONSTRATED INCREASED UPTAKE AROUND THE ACETABULAR COMPONENT, WHICH IS CONSISTENT WITH LOOSENING. THE ACETABULAR COMPONENT AND THE HEAD WERE REMOVED FROM THE FEMORAL COMPONENT. HIP WAS NOTABLY STABLE THROUGHOUT WITH A FULL RANGE OF MOTION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER THE INVESTIGATION OF THIS EVENT. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2017-02608.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD A SECOND REVISION APPROXIMATELY 14 YEARS AFTER THE INDEX PROCEDURE DUE TO LOOSENING OF THE ACETABULAR SHELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893620 TI LOW PROFILE SCREW 6.5X25MM HIP, PROSTHESIS LPH BIOMET ORTHOPEDICS LLC N/A 862500

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R SEE H10