BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 OSSEOTI 4 HOLE SHELL 56MM F

    MDR report key: 10739485 · Received October 27, 2020

    Report

    Report Number
    0001825034-2020-03886
    Event Type
    Injury
    Date Received
    October 27, 2020
    Date of Event
    July 20, 2020
    Report Date
    December 23, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K140669
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED VIA REVIEW OF MEDICAL RECORDS AND RADIOGRAPHS BY A HEALTH CARE PROFESSIONAL. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. ROOT CAUSE OF THE EVENT COULD NOT 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 FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CAT#: 00877502802 BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 28/0, TAPER 12/14 LOT# 299092. CAT# 110024464 G7 DUAL MOBILITY LINER 44MM F LOT# 424190. CAT# EP-200150 ACT ARTIC E1 HIP BRG 28X44MM LOT# 791850. CAT# 00771101100 FEMORAL STEM 12/14 NECK TAPER PLASMA LOT# 64172550. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS THE DEVICE REMAINS IMPLANTED; 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: 0001822565 - 2020 - 03633, 0001825034 - 2020 - 03887, 0001825034 - 2020 - 03888.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY PERFORMED APPROXIMATELY ONE YEAR AGO. AT THE ONE-YEAR VISIT, THE PATIENT REPORTED MODERATE PAIN AND A NEW ONSET LIMP. NO INTERVENTION OR FURTHER COMPLICATIONS NOTED AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203965 G7 OSSEOTI 4 HOLE SHELL 56MM F PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 6492270

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other SEE H10 NARRATIVE