BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN PROLONG ARTICULAR SURFACE

    MDR report key: 5099239 · Received September 23, 2015

    Report

    Report Number
    2648920-2015-00346
    Event Type
    Injury
    Date Received
    September 23, 2015
    Date of Event
    June 7, 2016
    Report Date
    January 8, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK042271
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OTHER DEVICES USED: CATALOG #00597206532, NEXGEN ALL POLY PATELLA, LOT #62676202; CATALOG #00596204010, NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE, LOT #62668124; CATALOG #00576401552, NEXGEN LPS-FLEX FEMORAL COMPONENT, LOT #62703303 -MANUFACTURED BY ZIMMER, (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE. THE INFORMATION PROVIDED ON THIS FORM WAS PREVIOUSLY SUBMITTED UNDER MANUFACTURING REPORT NUMBER 1822565-2015-01404.

    Additional Manufacturer Narrative · 1

    NO DEVICES AND PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. THESE DEVICES ARE USED FOR TREATMENT. SURGICAL NOTES WERE RECEIVED. REVIEW OF THE PRIMARY NOTES CONFIRMS THAT THE PATIENT UNDERWENT A RIGHT TOTAL KNEE REPLACEMENT ON (B)(6) 2014, DUE TO ADVANCED DEGENERATIVE JOINT DISEASE IN THE RIGHT KNEE. NOTES STATED THAT THE TRIAL COMPONENTS PROVIDED EXCELLENT STABILITY MEDIALLY AND LATERALLY; FULL EXTENSION PAST 120 DEGREES WAS ACHIEVED AND WAS STABLE IN FLEXION AND EXTENSION. INTEGRITY OF FIXATION WAS CONFIRMED. PATIENT WAS IN SATISFACTORY CONDITION POST-OP. DURING BOTH OFFICE VISITS ON (B)(6) 2015, PATIENT HAD RANGE OF MOTION FROM FULL EXTENSION TO ABOUT 130 DEGREES OF FLEXION. PATIENT HAS NO INSTABILITY, NO CREPITATION, NO ERYTHEMA, NO EVIDENCE OF INFECTION, NO EVIDENCE OF JOINT EFFUSION AND NO EVIDENCE OF COMPLEX REGIONAL PAIN SYNDROME. PATELLOFEMORAL JOINT TRACKED NORMALLY AND THE PATIENT WAS ADVISED TO CONTINUE WITH MOTION EXERCISES. A COMPLAINT HISTORY SEARCH BASED ON THE PART AND LOT COMBINATIONS REVEALED NO SIMILAR COMPLAINTS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. PRODUCT LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED AN MDR SHOULD NOT HAVE BEEN FILED UNDER THE CURRENT MFR NUMBER. THIS EVENT WILL BE REPORTED ON 1822565 - 2015 - 01404.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES AND MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. PER THE PACKAGE INSERT, PAIN IS A KNOWN POTENTIAL ADVERSE EFFECT OF THE TKA PROCEDURE. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT 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 IS EXPERIENCING POSTOPERATIVE PROBLEMS WITH THE IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS PAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS PAIN. REVIEW OF THE REVISION NOTES INDICATES THAT THE EXAMINATION OF THE PATELLA SHOWED THAT THE PATELLA WAS NOTED TO BE INTACT. THE FEMORAL COMPONENT WAS NOTED TO BE INTACT WITHOUT ANY EVIDENCE OF LOOSENING AS WELL AS THE TIBIAL COMPONENT. OSTEOTOME TAPPING WITH THE BONE MALLET REVEALED NO LOOSENING OF BOTH THE FEMORAL OR TIBIAL COMPONENT. THE PATELLA WAS NOTED TO ALSO BE TRACKING APPROXIMATELY. THE POLYETHYLENE LINER WAS REPLACED AND PATIENT HAD FULL RANGE OF MOTION. ONLY THE ARTICULAR SURFACE WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629926 NEXGEN PROLONG ARTICULAR SURFACE JWH JWH ZIMMER BIOMET, INC. N/A 62668124

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| O| R