BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 LONGEVITY NEUTRAL

    MDR report key: 9953426 · Received April 13, 2020

    Report

    Report Number
    0001825034-2020-01626
    Event Type
    Injury
    Date Received
    April 13, 2020
    Date of Event
    March 13, 2020
    Report Date
    July 1, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K190660
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 12-115121 ¿ BIOLOX DELTA HEAD ¿ 2986123 51-105170 ¿ TAPERLOC STEM ¿ 6238862 010000666 ¿ G7 SHELL ¿ 6460520.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: G4; H2; H3; H6. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS NOTING DISLOCATION ON THE SAME DATE AS ANTERIOR POSTOP IN RECOVERY ROOM. MANIPULATION OF HIP UNDER SEDATION. X-RAY REVEALED AN UNSTABLE HIP AND PATIENT BROUGHT BACK TO OR FOR REVISION. STEM WAS REVISED TO A HIGH OFFSET AND CABLE WITH CRIMP WAS PLACED TO AVOID FEMUR FRACTURE. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE IS 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 · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 650-1058 ¿ CERAMIC HEAD ¿ 2904573, 650-1067 ¿ CERAMIC TAPER - 2942374, 00625006525 ¿ BONE SCREW ¿ 64567716, 51-104180 ¿ TAPERLOC FEMORAL STEM ¿ 6466410. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR THE INVESTIGATION AS THE PRODUCT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT EXPERIENCED A RIGHT HIP ANTERIOR DISLOCATION IN THE RECOVERY ROOM AFTER AN INITIAL TOTAL HIP ARTHROPLASTY. MANIPULATION UNDER SEDATION WAS PREFORMED, THEN X-RAYS REVEALED AN UNSTABLE HIP. THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM WHERE THE STEM, HEAD AND LINER WERE REMOVED AND REPLACED. 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
    415657 G7 LONGEVITY NEUTRAL PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 64415463

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R