BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 OSSEOTI MULTIHOLE 52MM E

    MDR report key: 15215811 · Received August 12, 2022

    Report

    Report Number
    0001825034-2022-01852
    Event Type
    Injury
    Date Received
    August 12, 2022
    Date of Event
    July 5, 2022
    Report Date
    August 23, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00887868356025
    PMA / PMN Number
    K140669
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 574202080 ¿ AVENIR STEM ¿ 3004661; 00625006520 ¿ BONE SCREW - J7161138; 00625006520 ¿ BONE SCREW - J7164199; 00625006520 ¿ BONE SCREW - J7211458; 00625006515 ¿ BONE SCREW - J7086160; 30103605 ¿ G7 VIT E LINER ¿ 65055858; 00877503603 ¿ BIOLOX CERAMIC HEAD - 3061317. REPORT SOURCE: JAPAN. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR THE INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT 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

    IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 2 WEEKS POST IMPLANTATION DUE TO THE CUP COMPONENT BEING UNSTABLE. DURING THE SURGERY, THE STEM WAS REMOVED IN ORDER TO WIDEN THE OPERATIVE FIELD AND FOUND TO APPEAR GRAY RATHER THAN WHITE AND SUSPECTED THE COATING WAS PEELING OFF. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1689454 G7 OSSEOTI MULTIHOLE 52MM E PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 7164631 00887868356025

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R