BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEM EXTENSION

    MDR report key: 7240015 · Received February 4, 2018

    Report

    Report Number
    0001822565-2018-00509
    Event Type
    Injury
    Date Received
    February 4, 2018
    Date of Event
    January 9, 2018
    Report Date
    June 19, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK872379
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: NEXGEN ROTATING HINGE KNEE FEMORAL COMPONENT CAT#: 00588001501, LOT#: 61511043, NEXGEN FEMORAL AUGMENTS CAT#: 00599003510, LOT#: 61338227, NEXGEN FEMORAL AUGMENTS CAT#: 00599003510, LOT#: 61643130, NEXGEN FEMORAL AUGMENTS CAT#: 00-5990-035-10, LOT#: 60308860. FOREIGN: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS:0001822565 - 2018 - 00506, 0001822565-2018-00507, 0001822565 - 2018 - 00508, 0001822565-2018-00509. PRODUCT LOCATION IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED AND PRODUCT RETURN. VISUAL INSPECTION OF THE RETURNED FEMORAL COMPONENT CONFIRMED THE FRACTURE AT THE TOP OF THE MATING CONE, THE PIECE(S) THAT FRACTURED OFF WAS/WERE ALSO RETURNED. VISUAL INSPECTION OF THE STEM EXTENSION FOUND THAT IT WAS NICKED, GOUGED, AND WORN IN THE MATING AREA, ESPECIALLY THE TAPER PORTION. REVIEW OF THE X-RAYS BY PRIVATE HCP INDICATES THAT THERE IS A LEFT TOTAL KNEE ARTHROPLASTY WITH FRACTURED FEMORAL COMPONENT AT THE JUNCTION OF THE FEMORAL SHAFT AND FEMORAL CONE WITH ANTERIOR TRANSLATION OF THE FEMORAL CONE. THERE APPEARS TO BE A FRACTURE AT THE JUNCTION OF THE FEMORAL DIAPHYSIS AND METAPHYSIS AS WELL IN THIS REGION. SUGGESTION OF SIGNIFICANT RADIOLUCENCY SURROUNDING THE FEMORAL CONE, POSSIBLY EVIDENCE OF OSTEOLYSIS. TIBIAL COMPONENT DEMONSTRATES POSSIBLE SUBSIDENCE WITH A METALLIC FRAGMENT SEEN POSTERIORLY ON THE LATERAL FILM. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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

    IT WAS REPORTED THAT THE PATIENT WAS REVISED EIGHT YEARS AFTER KNEE ARTHROPLASTY DUE TO FEMORAL CONE FRACTURE AND DISASSOCIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83484 NEXGEN STEM EXTENSION PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 60592147

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R