BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VG DA360 TIB BRG ARCM 71/75X16

    MDR report key: 12561020 · Received October 1, 2021

    Report

    Report Number
    3002806535-2021-00432
    Event Type
    Injury
    Date Received
    October 1, 2021
    Report Date
    December 3, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    UDI-DI
    05019279376162
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SUMMARY: NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THIS DEVICE IS USED FOR TREATMENT. NO COMPATIBILITY ISSUES WERE NOTED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A REVIEW OF COMPLAINT HISTORY WAS ASSESSED FOR THREE YEARS PRIOR TO THE NOTIFICATION DATE AND IDENTIFIED (1) SIMILAR COMPLAINT FOR ITEM #161431 (INCLUDING INITIATING COMPLAINTS), AND (1) SIMILAR COMPLAINT FOR ITEM #161449 (INCLUDING INITIATING COMPLAINTS). A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND FURTHER INVESTIGATED. CAPA: NO CORRECTIVE OR PREVENTIVE ACTION REQUIRED AT THIS TIME. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 3002806535-2021-00431-1. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE SUBMITTED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 3 YEARS POSTOP, THE PATIENT UNDERWENT A MANIPULATION UNDER ANAESTHESIA 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.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. REPORT SOURCE - FOREIGN: (B)(6). MEDICAL PRODUCT: 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; MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2021-00431. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT REMAINS IMPLANTED.

    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 ANAESTHESIA 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
    1459087 VG DA360 TIB BRG ARCM 71/75X16 KNEE PROTHESIS JWH BIOMET UK LTD. N/A 3267971 05019279376162

    Patients

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