BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE

    MDR report key: 6069334 · Received November 1, 2016

    Report

    Report Number
    0001822565-2016-03950
    Event Type
    Injury
    Date Received
    November 1, 2016
    Date of Event
    September 7, 2016
    Report Date
    July 3, 2018
    Manufacturer
    ZIMMER, INC.
    Product Code
    KRO
    PMA / PMN Number
    PK013385
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT - NEXGEN RHK FEMORAL SIZE F, RT CATALOG# 00-5880-016-02 LOT#UNKNOWN. NEXGEN RHK TIBIAL PLATE, SIZE 4 CATALOG# 00-5880-004-00 LOT# UNKNOWN. STRAIGHT STEM EXTENSION 12.7MM X 75MM CATALOG# 00-5988-012-12 LOT# UNKNOWN. NEXGEN STRAIGHT STEM EXTENSION 15MM X 75MM CATALOG# 00-5988-012-15 LOT# UNKNOWN. NEXGEN 10MM RHK FULL BLOCK TIBIAL AUGMENT, SIZE 4 CATALOG# 00-5880-004-10 LOT# UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 9B)(4). CONCOMITANT MEDICAL PRODUCTS: NEXGEN RHK FEMORAL SIZE F, RT CATALOG# 00-5880-016-02 LOT# 63058063. NEXGEN RHK TIBIAL PLATE, SIZE 4 CATALOG# 00-5880-004-00 LOT# 62672628. STRAIGHT STEM EXTENSION 12.7 MM X 75 MM CATALOG# 00-5988-012-12 LOT# 62484915. NEXGEN STRAIGHT STEM EXTENSION 15 MM X 75 MM CATALOG# 00-5988-012-15 LOT# 62353235. NEXGEN 10 MM RHK FULL BLOCK TIBIAL AUGMENT, SIZE 4 CATALOG# 00-5880-004-10 LOT# 62627426. NG PRE FEM AUG SZ F 10 POST CATALOG# 00-5990-036-02 LOT# 62111721. ALL-POLY PATELLA CEMENTED 35 MM DIAMETER CATALOG# 42540200035 LOT# 63321035.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CONCOMITANT MEDICAL PRODUCTS- ARTICULAR SURFACE WITH SEGMENTAL HINGE POST SIZE F 12 MM HEIGHT, CATALOG # 00585006012, LOT # 63207516. ANOTHER REPORT WAS FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT:

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS ABLE TO BE CONFIRMED VIA OPERATIVE NOTES. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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 · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION DUE TO PAIN, SWELLING AND DISLOCATION AFTER A FALL. OPERATIVE NOTES RECEIVED FOR THE PATIENT¿S INITIAL ROTATING HINGE KNEE IMPLANTATION SURGERY (REMOVAL OF ANTIBIOTIC SPACERS) STATES THAT THE PATIENT HAD A PRIOR KNEE DISLOCATION DUE TO SEVERE SEPTIC ARTHRITIS. FULL EXTENSION, FLEXION GREATER THAN 90 DEGREES AND EXCELLENT STABILITY WERE NOTED AFTER THE FINAL COMPONENTS WERE PLACED AND THE BONE CEMENT WAS CURED. NO COMPLICATIONS WERE NOTED. OPERATIVE NOTES RECEIVED FOR THE PATIENT¿S REVISION SURGERY STATE THAT THE PATIENT WAS REVISED DUE TO A DISLOCATED TOTAL KNEE. DURING THE PROCEDURE, IT WAS IDENTIFIED THAT THE HINGE POST EXTENSION HAD BACKED OUT OF THE THREADS. THE FEMORAL COMPONENT WAS NOTED TO BE UNDAMAGED. A HINGE SERVICE KIT WAS USED TO REPLACE THE HINGE MECHANISM.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT KNEE ARTHROPLASTY REVISION DUE TO PAIN, SWELLING AND KNEE FRACTURE AFTER SUSTAINING A FALL.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT KNEE ARTHROPLASTY REVISION DUE TO PAIN, SWELLING AND KNEE FRACTURE AFTER SUSTAINING A FALL. ADDITIONAL OPERATIVE NOTES WERE RECEIVED STATING THAT THE PATIENT WAS REVISED DUE TO A DISLOCATED TOTAL KNEE AND STRETCHED EXTENSOR MECHANISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722446 NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE KNEE PROSTHESIS KRO ZIMMER, INC. N/A 63229220

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R