BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGENEREX (TM) RINGLOC MULTI HOLE ACETABULAR CUP

    MDR report key: 7819297 · Received August 27, 2018

    Report

    Report Number
    0001825034-2018-08522
    Event Type
    Injury
    Date Received
    August 27, 2018
    Date of Event
    August 25, 2014
    Report Date
    June 20, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK070369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. XRAYS DEMONSTRATE PROTRUSION, LOOSENING, AND MIGRATION OF THE ACETABULAR COMPONENT. LARGE EFFUSION NOTED WITH DISRUPTION OF POSTERIOR EXTERNAL ROTATOR REPAIR. FEMORAL COMPONENT NOT LOOSE BUT REMOVED DUE TO LEG LENGTH INEQUALITY. UNABLE TO REMOVE COMPONENT, SO TROCHANTERIC OSTEOTOMY WAS PERFORMED. CABLES USED TO STABILIZE OSTEOTOMY. DEVICE HISTORY RECORD 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT HIP REVISION DUE TO PAIN, DISLOCATION, LOOSENING AND MIGRATION OF ACETABULAR COMPONENT FIVE MONTHS POST IMPLANTATION. DURING SURGERY, LARGE EFFUSION NOTED WITH DISRUPTION OF POSTERIOR EXTERNAL ROTATOR REPAIR FEMORAL COMPONENT NOT LOOSE BUT REMOVED DUE TO LEG LENGTH INEQUALITY. UNABLE TO REMOVE COMPONENT, SO TROCHANTERIC OSTEOTOMY WAS PERFORMED CABLES USED TO STABILIZE OSTEOTOMY.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - FREEDOM CONSTRAIN HEAD # ITEM 11-107016 LOT 340950, FREEDOM CONSTRAIN LINER # ITEM 11-107022 LOT 436220, TI LOW PROFILE SCREW # ITEM 103534 LOT 925870 , TI LOW PROFILE SCREW # ITEM 103534 LOT 61190, TAPERLOC MICRO LAT FEMORAL # ITEM 15-103207 LOT 413780, TI LOW PROFILE SCREW # ITEM 103531 LOT 171810. IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT HIP REVISION DUE TO PAIN, DISLOCATION, LOOSENING AND MIGRATION OF ACETABULAR COMPONENT FIVE MONTHS POST IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658907 REGENEREX (TM) RINGLOC MULTI HOLE ACETABULAR CUP PROSTHESIS HIP LPH ZIMMER BIOMET, INC. N/A 641640

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R