BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEMMED TIBIAL COMPONENT

    MDR report key: 5941811 · Received September 10, 2016

    Report

    Report Number
    0001822565-2016-03214
    Event Type
    Injury
    Date Received
    September 10, 2016
    Report Date
    April 14, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK963148
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 LEFT CATALOG# 00-5994-014-91 LOT# 62380093, ZIMMER NEXGEN LCCK ARTICULAR SURFACE, SIZE STRIPED PURPLE/CD 14MM CATALOG# 00-5994-022-14 LOT# 61692296, ZIMMER NEXGEN STEM EXTENSION STRAIGHT, 15MM DIA X 30MM LENGTH CATALOG# 00-5988-012-15 LOT# 82380775, ZIMMER NEXGEN STEM EXTENSION STRAIGHT, 13MM DIA X 100MM LENGTH CATALOG# 00-5988-010-13 LOT# 37108380, ZIMMER ALL POLY PATELLA SIZE 29MM DIA. CATALOG# 00-5972-065-29 LOT# 60997235, ZIMMER NEXGEN TM POSTERIOR FEMORAL AUGMENT BLOCK, SIZE D, 5MM CATALOG# 00-5490-034-01 LOT# 62414316, ZIMMER NEXGEN TM POSTERIOR FEMORAL AUGMENT BLOCK, SIZE D, 5MM CATALOG# 00-5490-034-01 LOT# 61951120, ZIMMER NEXGEN TM DISTAL FEMORAL AUGMENT BLOCK, SIZE D, 10MM CATALOG# 00-5490-034-20 LOT# 62193358, ZIMMER NEXGEN TM DISTAL FEMORAL AUGMENT BLOCK, SIZE D, 10MM CATALOG# 00-5490-034-20 LOT# 62005533, PALACOS R+G RADIOPAQUE BONE CEMENT CATALOG# 00-1113-140-01 LOT# 77134384, PALACOS R+G RADIOPAQUE BONE CEMENT CATALOG# 00-1113-140-01 LOT# 77134384. 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 LEFT 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. MOREOVER, OP NOTES SHOW THERE EXIST 5 DEGREE HYPEXTENSION AFTER REVISION SURGERY. 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 PAIN IS ADDRESSED AS POSSIBLE ADVERSE EFFECT OF THIS PROCEDURE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION 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: 0001822565-2016-03215-1. 0001822565-2016-03216-1. 0002648920-2016-03161-1. 0002648920-2016-03162-1. 0002648920-2016-03160-1. FOUR OTHER COMPLAINTS ALSO RELATED TO THIS EVENT FOR THE PATIENT: (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593210 NEXGEN STEMMED TIBIAL COMPONENT KNEE PROSTHESIS JWH ZIMMER, INC. 62464808

    Patients

    Seq Age Sex Outcome Treatment
    1 Other