BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET 360 TIB 5.0 OFFSET ADAPTER

    MDR report key: 12547033 · Received September 29, 2021

    Report

    Report Number
    0001825034-2021-02751
    Event Type
    Injury
    Date Received
    September 29, 2021
    Date of Event
    September 3, 2018
    Report Date
    February 15, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K093293
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE RESULTS OF THE INVESTIGATION ARE AS FOLLOWS: 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. JOINT ASSIST RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW FOUND PRESENTED WITH PAIN AND PROBLEMS WALKING. THE PATIENT RECEIVED AN MANIPULATION UNDER ANESTHESIA. PATIENT CONTINUED TO HAVE PAIN, WALKING PROBLEMS, RANGE OF MOTION WAS 0-30 DEG. X-RAYS REVEALED NO COMPLICATIONS. PATIENT HAS RHEUMATOID ARTHRITIS. FURTHER MEDICAL RECORDS WERE NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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.

    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: VNGD SSK 360 FEMUR L 67.55 CATALOG #: 185285 LOT: 3444874; BMT SMOOTH KNEE STEM 14X80 CATALOG #: 145024 LOT: 304650; VG DA 360 O/S TIB TRAY COCR 75 CATALOG #: 161431 LOT: 3548240; BIOMET SMOOTH KNEE STEMS 10X40 CATALOG #: 145000 LOT: 458990; BMT 360 TIB 5.0 OFFSET ADAPTER CATALOG #: 185211 LOT: 497590; VG DA360 TIB BRG ARCM 71/75X16 CATALOG #: 161449 LOT: 3267971. REPORT SOURCE - FOREIGN: (B)(6). 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 REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2021 -02747 , 0001825034 -2021 -02748 , 0001825034 -2021 -02749, 0001825034 -2021 -02750 , 0001825034 -2021-02752 . INVESTIGATION INCOMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 3 YEARS POSTOP, THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA WITH 48 HOURS OF INPATIENT PHYSICAL THERAPY DUE TO LIMITED FLEXION AND EXTENSION. THE PATIENT CONTINUED TO EXPERIENCED A DECREASE IN RANGE OF MOTION WITH DEBILITATING PAIN AND INABILITY TO PERFORM ADLS. AT THE 7 YEAR FOLLOW UP THE PATIENT STATES THAT DUE TO RHEUMATOID ARTHRITIS THEY ARE ALWAYS IN PAIN AND HAVE DIFFICULTY WALKING AND RISING ETC. BUT THE KNEE NEVER GIVES ANY PROBLEMS WITH PAIN OR MOVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447579 BIOMET 360 TIB 5.0 OFFSET ADAPTER PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 497590

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Hospitalization| R SEE H10 NARRATIVE.