BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 RINGLOC ACETABULAR LINER

    MDR report key: 6652946 · Received June 20, 2017

    Report

    Report Number
    0001825034-2017-03831
    Event Type
    Injury
    Date Received
    June 20, 2017
    Date of Event
    May 25, 2017
    Report Date
    April 9, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK090103
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: EP-108322 E-POLY 32MM +3 HIWALL LNR SZ22 491650, 163669 32MM MOD HEAD COCR STD NECK 988510, 11-106048 R/B RLOC LHOLE SHL 48MM SZ22 517710, 192411 ECHO POR FMRL RED NC 11X135MM 335960. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EVALUATION SHOWS THE ACETABULAR E1 BEARING SHOWS SIGNS OF POTENTIAL FRACTURE ALONG THE LIP/EDGE OF THE BEARING . THE FEMORAL HEAD SHOWS SIGNS OF POSSIBLE ABRASIONS. THE ACETABULAR SHELL WAS NOT RETURNED.AS STATED IN THE SEM ANALYSIS REPORT THERE IS A EVIDENCE FOR POTENTIAL IMPINGEMENT ON THE INTACT BEARING RIM NEAR THE TRANSITION TO THE HIGH-WALL REGION OF THE RIM. 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. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - ECHO POR FMRL RED NC 11X135/ PN 192411/ LN 335960, R/B RLOC LHOLE SHL 48MM SZ22/ PN 11-106048/ LN 517710, 32MM MOD HEAD COCR STD NECK/ PN 163669/ LN 988510. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP REVISION PROCEDURE APPROXIMATELY FIVE YEARS POST IMPLANTATION DUE TO BREAKAGE, DISLOCATION, AUDIBLE CLICKING SOUND, INSTABILITY, AND PAIN. THE SURGERY WAS UNEVENTFUL AS WAS HER REHAB AND POSTOPERATIVE PERIOD. DURING THE SURGERY IT WAS FOUND THAT THE LINER WAS BROKEN, THE FEMORAL HEAD HAD DEFORMED THE SHELL TO THE POINT THAT THE SHELL HAD TO BE REMOVED AND A NEW SHELL IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435088 E1 RINGLOC ACETABULAR LINER PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 491650

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R