BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEMMED FLUTED TIBIAL COMPONENT

    MDR report key: 3587718 · Received December 23, 2013

    Report

    Report Number
    1822565-2013-01877
    Event Type
    Injury
    Date Received
    December 23, 2013
    Date of Event
    January 20, 2014
    Report Date
    February 14, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. EVALUATION CODES: REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. EVALUATION CODES: REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED. OTHER DEVICES USED: THE FOLLOWING BONE CEMENT IS MANUFACTURED AT HERAEUS MEDICAL AND DISTRIBUTED THROUGH ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS. CATALOG #00111214001, PALACOS RADIOPAQUE BONE CEMENT, LOT #65614105; CATALOG #00111314001, PALACOS R+G BONE CEMENT, LOT #65584099. INVESTIGATION UPDATE AFTER PRODUCT EVALUATION VISUAL EXAMINATION OF THE RETURNED IMPLANTS SHOWS THE BACKSIDE OF THE TIBIAL COMPONENT IS COMPLETELY FREE OF BONE CEMENT AND IS SCRATCHED WHILE THE SUPERIOR SURFACE EXHIBITS PITTING AND/OR MICRO-MOTION LINES. THE BACKSIDE OF THE FEMORAL COMPONENT IS COVERED WITH BONE CEMENT REMAINS. THE POLISHED CONDYLAR SURFACES OF THE FEMORAL COMPONENT ARE SLIGHTLY WORN/TARNISHED. BOTH THE SUPERIOR AND INFERIOR SURFACES OF THE ARTICULAR SURFACE ARE SCRATCHES AND PITTED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE PRIMARY OPERATIVE NOTES INDICATE THAT THE TIBIAL, FEMORAL, AND PATELLAR COMPONENTS WERE CEMENTED INTO PLACE AND THE KNEE WAS PLACED THROUGH A FULL RANGE OF MOTION PRIOR TO THE CEMENT HARDENING; WHICH IS A DEVIATION FROM THE SURGICAL TECHNIQUE. REVISION OPERATIVE NOTES STATE THAT X-RAYS INDICATED QUESTIONABLE TIBIAL LOOSENING AND A BONE SCAN WAS ALSO CONSISTENT WITH LOOSENING PRIOR TO REVISION. UPON ENTERING THE JOINT, A SEVERE, GREENISH GRAY, PROLIFERATIVE SYNOVITIS MASS INVOLVING THE ENTIRE KNEE WAS FOUND AND EXCISED. THE MASS HAD SOMEWHAT THE APPEARANCE SEEN WITH METALLOSIS. THE TIBIAL COMPONENT WAS GROSSLY LOOSE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT 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 KNEE PAIN AND SWELLING. LOOSENING OF THE TIBIAL COMPONENT IS ALSO REPORTED. A REVISION SURGERY HAS BEEN SCHEDULED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS EXPERIENCING KNEE PAIN AND SWELLING. LOOSENING OF THE TIBIAL COMPONENT IS ALSO REPORTED. A REVISION SURGERY HAS BEEN SCHEDULED. IT IS FURTHER REPORTED THAT THE PATIENT HAS BEEN REVISED DUE TO TIBIAL LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672692 NEXGEN STEMMED FLUTED TIBIAL COMPONENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 60697414

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| O| R