BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION CR FEMORAL COMPONENT

    MDR report key: 6271974 · Received January 23, 2017

    Report

    Report Number
    0001822565-2017-00332
    Event Type
    Injury
    Date Received
    January 23, 2017
    Date of Event
    March 7, 2011
    Report Date
    June 2, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK933785
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS REPORT IS NUMBER 3 OF 7 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1822565-2017-00023, 00330, 00332, 00018, 00334, 00336 AND 2648920-2017-00033).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. INVESTIGATION RESULTS CONCLUDED THAT, PER THE PACKAGING INSERTS ASSOCIATED WITH THE DEVICES (87-6203-453-22 REV A. FOR THE TIBIA, FEMUR AND ARTICULAR SURFACE. 87-6203-614-01 REV. D FOR THE PATELLA) POST-OPERATIVE PAIN IS A KNOWN ADVERSE EFFECT ASSOCIATED WITH THIS PROCEDURE. THEREFORE, A DEFINITIVE ROOT CAUSE FOR THE PAIN CANNOT BE DETERMINED AT THIS TIME. NO CORRECTIVE OR PREVENTIVE ACTIONS NEEDED AT THIS TIME. THIS COMPLAINT WAS DETERMINED NOT TO BE A NEW CONFIRMED QUALITY OR MANUFACTURING ISSUE.THE DEVICES REMAIN IMPLANTED AND ARE THEREFORE NOT AVAILABLE FOR FURTHER EVALUATION.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT PRODUCTS: TIBIAL COMPONENT PEGGED PRECOAT SIZE 5 CATALOG#: 00597004501 LOT#: 61672548, ARTICULAR SURFACE USE WITH PLATE 5,6 SIZE GREEN/C-H 14 MM HEIGHT CATALOG# 00595204014 LOT# 61683086, ALL POLY PATELLA SIZE 32 MM DIA. STANDARD 8.5 MM THICKNESS CATALOG# 00597206532 LOT# 61708907. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. OPERATIVE NOTES WERE RECEIVED FOR THE PRIMARY SURGERY THAT TOOK PLACE ON (B)(6) 2011. THE INDICATION FOR THE PROCEDURE WAS BILATERAL DEGENERATIVE JOINT DISEASE. DURING THE PROCEDURE, IT WAS INDICATED THAT THE RIGHT KNEE WAS THE FIRST TO BE OPERATED ON. TO OBTAIN OPTIMAL LIGAMENT BALANCE AS WELL AS FLEXION EXTENSION GAPS, THE MCL WAS STRIPPED PROXIMALLY TO THE TIBIA. FINAL TRIALING OF THE COMPONENTS REVEALED THAT A 14 SPACER WAS NEEDED TO ALLOW FOR FULL EXTENSION WITH STABILITY. THIS COMPONENT WAS THEN IMPLANTED. THE LATEST VISIT NOTES FROM (B)(6) 2016 FOUND THAT THE PATIENT WAS COMPLAINING OF BILATERAL KNEE PAIN. DURING THE PHYSICAL EXAMINATION THAT WAS PERFORMED, THE RANGE OF MOTION OF THE KNEE WAS ONLY 0-90 DEGREES BUT WITH NO INSTABILITY. THE PHYSICIAN NOTED THAT THE X-RAYS OF BOTH KNEES FOUND NO FURTHER INDICATION AS BOTH WERE IN GOOD POSITION WITH NO EVIDENCE OF LUCENCY. THE PATIENT APPEARS TO HAVE FOLLOWED THE PHYSICAL THERAPY ROUTINE THAT WAS INSTRUCTED BY THE PHYSICIAN AND WAS MAKING IMPROVEMENTS IN PAIN AND RANGE OF MOTION. DEVICE HISTORY RECORDS WERE REVIEWED WITH NO DISCREPANCIES FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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.

    Description of Event or Problem · 1

    PATIENT REPORTED EXPERIENCING RIGHT KNEE PAIN APPROXIMATELY FIVE YEARS POST-IMPLANTATION. ADDITIONAL INFORMATION RECEIVED IN PATIENT'S MEDICAL RECORDS INDICATE PATIENT UNDERWENT PHYSICAL THERAPY FOR THREE MONTHS POST-OPERATIVELY AND HAS RESUMED PHYSICAL THERAPY AGAIN, FIVE YEARS POST-IMPLANTATION DUE TO LIMITED RANGE OF MOTION, STIFFNESS AND PAIN IN RIGHT KNEE. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54142 NEXGEN COMPLETE KNEE SOLUTION CR FEMORAL COMPONENT PROSTHESIS, KNEE JWH ZIMMER, INC. N/A 61670572

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other