BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL RINGLOC 2-HOLE SHELL

    MDR report key: 6583099 · Received May 22, 2017

    Report

    Report Number
    0001825034-2017-03189
    Event Type
    Injury
    Date Received
    May 22, 2017
    Date of Event
    September 25, 2016
    Report Date
    May 22, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCTS - BENCOX DELTA HEAD: PN 01.01.041, LN 20DAN01015 AND PN 01.01.28, LN 133279 UNIVERSAL 2-HOLE LINER P/N 14-103648 L/N 225330 E-POLY LINER P/N EP-105882 L/N 490120. REPORT SOURCE - (B)(6). REPORTED EVENT COULD NOT BE CONFIRMED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. THE INFORMATION PROVIDED INDICATES THE ACETABULAR SHELL WAS IN 5 DEGREES RETROVERSION; HOWEVER, THE SURGICAL TECHNIQUE INDICATES THE SHELL SHOULD BE PLACED AT APPROXIMATELY 20 DEGREES ANTEVERSION DEPENDING ON PATIENT ANATOMY. WITH THE AVAILABLE INFORMATION, THE ROOT CAUSE OF THE EVENT CAN BE ATTRIBUTED TO MALPOSITIONING OR MIGRATION OF THE SHELL. 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 PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY TWELVE MONTHS POST-OPERATIVELY DUE TO RECURRENT DISLOCATION WITH ONSET APPROXIMATELY ONE MONTH POST-OPERATIVELY. INFORMATION PROVIDED INDICATED THAT THE HIP WAS IN 5 DEGREES OF RETROVERSION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363104 UNIVERSAL RINGLOC 2-HOLE SHELL PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 225330

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization| R