BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN PROLONG LPS FLEX ARTICULAR SURFACE

    MDR report key: 6515274 · Received April 24, 2017

    Report

    Report Number
    0001822565-2017-02196
    Event Type
    Injury
    Date Received
    April 24, 2017
    Date of Event
    October 22, 2013
    Report Date
    April 21, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK042271
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT PROVIDED FOR NEW ADDED ITEM (ARTICULAR SURFACE) WHICH MAY RELATE TO THE EVENT. METHODS: ACTUAL DEVICE NOT EVALUATED, MANUFACTURING REVIEW, RESULTS: NO FAILURE DETECTED, NON FUNCTIONAL DEFECT, CONCLUSIONS: KNOWN INHERENT RISK OF PROCEDURE, UNABLE TO CONFIRM COMPLAINT. MEDICAL PRODUCT: ZIMMER NEXGEN LPS-FLEX GSF FEMORAL COMPONENT OPTION (CATALOG# 00-5764-014-51, LOT# 60955477), ZIMMER NEXGEN FLUTED STEMMED TIBIAL COMPONENT (CATALOG# 00-5996-028-01, LOT# 60582732), ZIMMER NEXGEN LPS-FLEX ARTICULAR SURFACE (CATALOG# 00-5962-022-10, LOT# 60970453), ZIMMER NEXGEN ALL POLY PATELLA (CATALOG# 00-5972-065-29, LOT# 60997235), ZIMMER PALACOS R RADIOPAQUE BONE CEMENT (CATALOG# 00-1112-140-01, LOT# 68834190). RECORDS RECEIVED STATED PATIENT UNDERWENT LEFT KNEE REVISION DUE TO INSTABILITY AND CONNECTIVE TISSUE LAXITY DISORDER AFTER ABOUT 5 YEARS FROM PRIMARY TKA AT 2008. PATIENT HAD OBVIOUS SYSTEMIC CONNECTIVE TISSUE DISORDER WITH LIGAMENTOUS LAXITY AND HYPEREXTENSION. THE PRIMARY SURGICAL NOTES STATE THAT THE PATIENT UNDERWENT TKA TO TREAT LEFT KNEE OSTEOARTHRITIS. TRIAL TIBIAL AND FEMORAL COMPONENTS WERE PLACED AND THE KNEE WAS TAKEN THROUGH RANGE OF MOTION. THE PATIENT'S RANGE OF MOTION, STABILITY AND SOFT TISSUE BALANCING WERE ASSESSED AND ALL WERE SATISFACTORY. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO ANOMALIES OR DEVIATIONS WERE IDENTIFIED THAT WOULD IMPACT THE REPORTED EVENT. A COMPLAINT HISTORY REVIEW REVEALED NO ADDITIONAL COMPLAINTS AGAINST THE RELATED PART AND LOT NUMBER COMBINATIONS. NEXGEN KNEE SYSTEM PACKAGING INSERT, JOINT INSTABILITY AND PAIN ARE ALSO ADDRESSED AS POSSIBLE ADVERSE EFFECTS IS A KNOWN RISK OF THIS PROCEDURE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001822565-2016-01008. NOT RETURNED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT PATIENT UNDERWENT TOTAL KNEE REVISION ARTHROPLASTY SURGERY DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297243 NEXGEN PROLONG LPS FLEX ARTICULAR SURFACE KNEE PROSTHESIS JWH ZIMMER, INC. N/A 60970453

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R