BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS RS 7 CM ELLIP SEG FMRL-LT

    MDR report key: 5923077 · Received September 1, 2016

    Report

    Report Number
    0001825034-2016-03426
    Event Type
    Injury
    Date Received
    September 1, 2016
    Date of Event
    February 20, 2015
    Report Date
    November 12, 2019
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK051479
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. SURGICAL NOTES IDENTIFIED THAT THE PATIENT WAS REVISED AND THE FEMORAL COMPONENT WAS LOOSE, AND EASILY REMOVED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS 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 FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(6). THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CONCOMITANT MEDICAL PRODUCTS: CATALOG #: 430054, THIN OSTEOTOME BLADE 12MM, LOT # 309490; CATALOG #: 150412, OSS TIB POLY BEARING 16, LOT # 804400; CATALOG #: 150476, OSS POLY TIBIAL BUSHING, LOT # 741800; CATALOG #: 161034, OSS RS FEM BUSHINGS, LOT # 456130; CATALOG #: 150493, OSS REINFORCED YOKE, LOT # 473660; CATALOG #: 161035, OSS RS AXLE, LOT # 884620; CATALOG #: 150478, OSS POLY LOCK PIN, LOT # 212950; CATALOG #: 161088, OSS MODULAR TIBIAL TRAY 63, LOT # 694510; CATALOG #: 150386, OSS P/C IM STEM 15.5X90, LOT # 427060; CATALOG #: 150382, OSS P/C IM STEM 11.5X90, LOT # 167500.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-03426 / 03427). PRODUCT LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ROOT CAUSE REMAINS UNKNOWN. 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 · 1

    THIS FOLLOW-UP REPORT 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 · 1

    PATIENT UNDERWENT A KNEE REVISION PROCEDURE APPROXIMATELY TWO YEARS POST IMPLANTATION DUE TO UNKNOWN REASONS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT A KNEE REVISION PROCEDURE APPROXIMATELY TWO YEARS POST IMPLANTATION DUE TO LOOSE, UNSTABLE LEFT TOTAL KNEE. PATIENT HAD SUBSEQUENT REVISIONS OVER THE NEXT FEW YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572861 OSS RS 7 CM ELLIP SEG FMRL-LT PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 611310

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R