BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX GSF FEMORAL COMPONENT

    MDR report key: 2318786 · Received October 27, 2011

    Report

    Report Number
    1822565-2011-02370
    Event Type
    Injury
    Date Received
    October 27, 2011
    Date of Event
    December 13, 2010
    Report Date
    April 29, 2020
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    K060370
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNK. SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY AND HEIGHT/WEIGHT ARE UNK. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. EVAL: 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 SPECS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    OTHER DEVICE USED: CATALOG #00598004701, NEXGEN STEMMED TIBIAL COMPONENT, LOT #61088548, MANUFACTURED AT ZIMMER (B)(4), CATALOG #00111314001, PALACOS R+G BONE CEMENT, LOT #67584194, THIS BONE CEMENT IS MANUFACTURED AT HERAEUS MEDICAL AND DISTRIBUTED THROUGH (B)(4). EVALUATION SUMMARY: THE NEW INFORMATION GIVES NO INDICATIONS OF A ROOT CAUSE. EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. 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 INVESTIGATION, 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED SURFACE SCRATCH, NICK, GOUGE, THESE DAMAGES WERE RELATED USE OF THE DEVICE IN VIVO AND EXPLANATION PROCESS. BONE CEMENT STILL ADHERED TO BOTH FEMORAL AND TIBIAL COMPONENTS. DIMENSIONS WERE MEASURED FOR BOTH FEMUR AND TIBIAL PLATE, WHICH FOUND TO BE CONFORMING TO THE PRINT SPECIFICATION. ALSO, THE ARTICULAR SURFACE AND TAPER PLUG WERE RETURNED. THE DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS WERE NOT PROVIDED. THERE IS NO CHANGE IN THE PREVIOUSLY FOUND ROOT CAUSE. PER PACKAGE INSERT NEXGEN CR-FLEX AND LPS-FLEX GENDER SOLUTIONS FEMALE (GSF), KNEE FEMORAL COMPONENTS): PAIN AND LOOSENING ARE KNOWN ADVERSE EFFECT OF THIS SYSTEM. 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 PT WAS REVISED FOR PAIN.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING.

    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
    1 NEXGEN LPS-FLEX GSF FEMORAL COMPONENT KNEE PROSTHESIS JWH ZIMMER, INC. 60960294

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention