BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 RINGLOC ACETABULAR LINER 28MM SIZE 22 MAX-ROM

    MDR report key: 6187385 · Received December 19, 2016

    Report

    Report Number
    0001825034-2016-05262
    Event Type
    Injury
    Date Received
    December 19, 2016
    Date of Event
    September 13, 2015
    Report Date
    May 19, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK070364
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPETITOR PRODUCTS: BENCOX DELTA HEAD: PN 01.01.041, LN 20DAN01015 AND PN 01.01.28, LN 1332791; UNIVERSAL RINGLOC 2-HOLE SHELL 48 MMLNR SZ 22; PN 14-103648, LN 225330.

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED SO NO PRODUCT EVALUATION COULD BE CONDUCTED, AND REPORTED EVENT CANNOT BE CONFIRMED. DEVICE HISTORY RECORD WAS REVIEWED WITH NO DEVIATIONS OR ANOMALIES NOTED. THIS DEVICE WAS USED FOR TREATMENT. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED WITH THE INFORMATION 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.

    Description of Event or Problem · 1

    PATIENT UNDERWENT LEFT HIP REVISION APPROXIMATELY TWELVE MONTHS POST-OPERATIVELY DUE TO RECURRENT DISLOCATION WITH ONSET APPROXIMATELY ONE MONTH POST-OPERATIVELY.

    Description of Event or Problem · 1

    PATIENT UNDERWENT 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837896 E1 RINGLOC ACETABULAR LINER 28MM SIZE 22 MAX-ROM HIP PROSTHESIS JDI BIOMET ORTHOPEDICS N/A 490120

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization| R