BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 ACETABULAR SYSTEM DUAL MOBILITY ACETABULAR LINER

    MDR report key: 6531175 · Received April 28, 2017

    Report

    Report Number
    0001825034-2017-02920
    Event Type
    Injury
    Date Received
    April 28, 2017
    Date of Event
    November 23, 2016
    Report Date
    September 21, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK150522
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 110010272 3578593 G7 OSSEOTI MULTIHOLE 68MM I HIP-OTHER-HEADS-UNK. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 02942.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS - G7 SCREW 6.5 MM X 20 MM CATALOG 010000997 LOT 3070479, G7 SCREW 6.5 MM X 20 MM 2 CATALOG 010000997 LOT 3822938, G7 OSSEOTI MULTIHOLE 68 MM CATALOG 110010272 LOT 3578593, G7 SCREW 6.5 MM X 40 MM CATALOG 010001001 LOT 3822962, ACT ARTIC E1 HIP BRG 28 X 54 MM CATALOG EP-200160 LOT 481810, UNKNOWN FEMORAL HEAD, UNKNOWN FEMORAL STEM. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTIONS ARE REQUIRED. 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 · 1

    IT WAS REPORTED THAT PATIENT¿S RIGHT HIP WAS REVISED APPROXIMATELY ON MONTH POST-IMPLANTATION DUE TO UNKNOWN REASON. IT WAS REPORTED THE PATIENT EXPERIENCED CHRONIC DISLOCATIONS CONTRIBUTING TO THE REVISION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311258 G7 ACETABULAR SYSTEM DUAL MOBILITY ACETABULAR LINER PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 879280

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R