BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX OPTION FEMORAL COMPONENT

    MDR report key: 4275190 · Received November 7, 2014

    Report

    Report Number
    1822565-2014-01551
    Event Type
    Injury
    Date Received
    November 7, 2014
    Date of Event
    March 12, 2012
    Report Date
    February 27, 2020
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    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. REHABILITATION PROTOCOL AND ADHERENCE THERETO IS UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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

    OTHER DEVICES USED: CATALOG #00598004702, NEXGEN STEMMED PRECOAT TIBIAL PLATE, LOT #61254281 - MANUFACTURED BY ZIMMER B V. (B)(4). CATALOG #00111214001, PALACOS R BONE CEMENT, LOT #69264223, QTY 2 - THIS BONE CEMENT IS MANUFACTURED AT HERAEUS MEDICAL AND DISTRIBUTED THROUGH ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS. UPDATED INFORMATION RECEIVED VIA REVISION OPERATIVE NOTES. REVIEW OF REVISION OPERATIVE NOTES INDICATES THE PATIENT PRESENTED WITH A RADIOLUCENT LINE IN THE TIBIAL COMPONENT, SIGNIFYING A POSSIBLE LOOSE TIBIAL COMPONENT, AS WELL AS MALALIGNMENT OF THE TIBIAL AND FEMORAL COMPONENTS. IT IS NOTED THAT THE TIBIAL COMPONENT WAS REMOVED WITHOUT MUCH DIFFICULTY AND WITH MINIMAL BONE LOSS. THE FEMORAL COMPONENT WAS REMOVED IN A SIMILAR FASHION. DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND CONFORMING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE RETURNED COMPONENTS (TIBIAL, FEMORAL, ARTICULAR SURFACE, AND TAPER PLUG IMPLANTS) IDENTIFIED SIGNS OF BEING IMPLANTED, WITH BONE CEMENT REMAINS ON THE MEDIAL SIDE AND POSTERO LATERAL SIDE OF THE TIBIAL IMPLANT. THERE WAS ALSO BONE CEMENT ON THE BACKSIDE OF THE FEMORAL IMPLANT. THE ARTICULAR SURFACE WAS SCRATCHED AS WELL. PARTIAL LOOSENING OF THE TIBIAL IMPLANT WAS CONFIRMED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY DEVIATIONS OR ANOMALIES DURING MANUFACTURING. PER THE INSTRUCTIONS FOR USE OF THE IMPLANTS, PAIN, LOOSENING, AND MALALIGNMENT ARE ALL KNOWN POTENTIAL ADVERSE EFFECTS ASSOCIATED WITH A TKA PROCEDURE. A ROOT CAUSE REMAINS UNDETERMINED. 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. OTHER DEVICES USED: CATALOG #00598004702, NEXGEN STEMMED PRECOAT TIBIAL PLATE, LOT #61254281 - MANUFACTURED BY ZIMMER B.V. (B)(4). CATALOG #00111214001, PALACOS R BONE CEMENT, LOT #69264223, QTY 2 - THIS BONE CEMENT IS MANUFACTURED AT HERAEUS MEDICAL AND DISTRIBUTED THROUGH ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN.

    Description of Event or Problem · 1

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717152 NEXGEN LPS-FLEX OPTION FEMORAL COMPONENT KNEE PROSTHESIS JWH ZIMMER, INC. 61370651

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention