BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 DUAL MOBILITY LINER 46MM G

    MDR report key: 6540714 · Received May 3, 2017

    Report

    Report Number
    0001825034-2017-02972
    Event Type
    Injury
    Date Received
    May 3, 2017
    Date of Event
    April 6, 2017
    Report Date
    September 22, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - ACT ARTIC E1 HIP BRG 28 X 46 MM/ PN EP-200152/ LN 131870, ECHO POR FMRL LAT NC 14 X 150/ PN 192114/ LN 258230, G7 FINNED 4 HOLE SHELL 60G/ PN 110017107/ LN 3737145. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT PRODUCTS: G7 FINNED 4 HOLE SHEL CATALOG 110017107 LOT 3737145, 28 MM COCR MOD HD CATALOG 163665 LOT 902610, ACT ARTIC E1 HIP BRG 2 CATALOG EP-200152 LOT 131870, ECHO POR FMRL LAT NC CATALOG 192114LOT 258230. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS:0001825034-2017-02973.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322615 G7 DUAL MOBILITY LINER 46MM G PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 718460

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R