BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STRAIGHT STEM EXTENSION

    MDR report key: 5941823 · Received September 10, 2016

    Report

    Report Number
    0002648920-2016-03165
    Event Type
    Injury
    Date Received
    September 10, 2016
    Report Date
    April 13, 2017
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    PMA / PMN Number
    PK872379
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED AND ADDITIONAL INFORMATION, WHICH WAS INCORRECT OR WAS NOT AVAILABLE AT THE TIME OF INITIAL FOLLOW UP. MEDICAL PRODUCT ¿ ZIMMER NEXGEN LCCK FEMORAL COMPONENT, SIZE D, RIGHT CATALOG# 00-5994-014-92 LOT# 62245192, ZIMMER NEXGEN FLUTED STEMMED TIBIAL COMPONENT, SIZE 2 CATALOG # 00-5998-028-02 LOT # 62297528, ZIMMER NEXGEN LCCK ARTICULAR SURFACE, SIZE STRIPED PURPLE C/D, 17MM CATALOG# 00-5994-022-17 LOT# 62075685, ZIMMER NEXGEN TM DISTAL FEMORAL AUGMENT BLOCK CATALOG# 00-5490-034-20 LOT# 62033434, ZIMMER NEXGEN TM DISTAL FEMORAL AUGMENT BLOCK CATALOG# 00-5490-034-20 LOT# 62255730, ZIMMER NEXGEN STEM EXTENSION STRAIGHT, 12MM 100MM CATALOG# 00-5998-012-15 LOT# 62283307, ZIMMER PALACOS R+G RADIOPAQUE BONE CEMENT CATALOG# 00-1113-140-01 LOT# 75564317, ZIMMER PALACOS R+G RADIOPAQUE BONE CEMENT CATALOG# 00-1113-140-01 LOT# 75564317, ZIMMER ALL POLY PATELLA CATALOG# 00-5972-065-29 LOT# 61140474. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE COMPATIBILITY MATRIX IDENTIFIED THAT ALL THE COMPONENTS ARE COMPATIBLE (FEMORAL WITH ARTICULAR SURFACE AND PATELLA; TIBIA WITH ARTICULAR SURFACE).SURGICAL NOTES FOR PRIMARY AND REVISION SURGERY WERE PROVIDED FOR REVIEW. THE INITIAL SURGERY INDICATES ADVANCED OSTEOARTHRITIS IN RIGHT KNEE AND OP NOTED SHOWED SURGICAL TECHNIQUES FOLLOWED BY SURGEON. HOWEVER, SHE HAD PROGRESSIVE LAXITY AND HYPEREXTENSION; SHE ALSO HAD SYSTEMATIC CONNECTIVE TISSUE DISORDER WITH LIGAMENTOUS LAXITY. THE TRIAL COMPONENTS WERE PUT IN PLACE AND WERE STABLE WITH GOOD EXTENSION AND FLEXION GAPS WITH CENTRAL PATELLAR TRACKING. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2016-03217-1, 0001822565-2016-03218-1, 0001822565-2016-03219-1, 0002648920-2016-03164-1, 0002648920-2016-03163-1. FOUR OTHER COMPLAINTS ALSO RELATED TO THIS EVENT FOR THE PATIENT: (B)(4).

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT FOLLOWING A TOTAL KNEE ARTHROPLASTY REVISION, THE PATIENT IS EXPERIENCING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593249 NEXGEN STRAIGHT STEM EXTENSION KNEE PROSTHESIS JWH ZIMMER MANUFACTURING B.V. 62021242

    Patients

    Seq Age Sex Outcome Treatment
    1 Other