BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX FEMORAL COMPONENT

    MDR report key: 2624442 · Received June 13, 2012

    Report

    Report Number
    1822565-2012-01243
    Event Type
    Injury
    Date Received
    June 13, 2012
    Report Date
    April 24, 2020
    Manufacturer
    ZIMMER INC
    Product Code
    NJL
    PMA / PMN Number
    K173057
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO DEVICE OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. NEITHER SURGICAL NOTES NOR X-RAYS WERE PROVIDED, THEREFORE FIT AND ORIENTATION COULD NOT BE EVALUATED. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL OR TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) ARE UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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 REPORT IS BEING AMENDED TO REFLECT CHANGES. OTHER DEVICES USED: CATALOG #00111214001, PALACOS R BONE CEMENT, LOT #67684200. CATALOG #00111214001, PALACOS R BONE CEMENT, LOT #67684201. THIS BONE CEMENT IS MANUFACTURED BY HERAEUS MEDICAL AND (CHECK AL THAT APPLY) DISTRIBUTED BY (B)(4) ORTHOPAEDIC SURGICAL PRODUCTS. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY. NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNKNOWN. FIT AND ORIENTATION COULD NOT BE EVALUATED WITHOUT X-RAYS AND SURGICAL NOTES. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL OR TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) ARE UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.. EVALUATION CODES. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. T IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOR 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 UPDATED, ADDITIONAL, AND CORRECTED INFORMATION. MEDICAL PRODUCTS: LPS-FLEX OPTION FEMORAL F-L; P/N: 00596401651, L/N: 60930940; ST PRC TIB PLT SIZE 5; P/N: 00598004701, L/N: 61101594; LPS-FLEX FXD MLD EF/5-6 17MM; P/N: 00596404017, L/N: 60489310; PALACOS R BONE CEMENT; P/N: 00111214001, L/N: 67684200; PALACOS R BONE CEMENT; P/N: 00111214001, L/N: 67684201; ALL POLY PATELLA; P/N: 00597206532, L/N: 61189526; TAPER PLUG; P/N: 00596009900, L/N: 61179427. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. VISUAL EXAMINATION OF THE RETURNED COMPONENTS (FEMORAL IMPLANT, TIBIAL IMPLANT, PATELLAR IMPLANT, ARTICULAR SURFACE WITH SECURING SCREW AND TAPER PLUG) NOTED THAT THEY EXHIBIT SIGNS OF BEING IMPLANTED AND EXPLANTED. THE BACKSIDE OF BOTH THE FEMORAL AND TIBIAL IMPLANTS IS COVERED WITH BONE CEMENT REMAINS. THE BUFFED CONDYLAR SURFACES OF THE FEMORAL IMPLANT AND THE SUPERIOR SIDE OF THE TIBIAL IMPLANT ARE WORN. BOTH THE INFERIOR AND SUPERIOR SURFACES OF THE ARTICULAR SURFACE FEATURES ARE DAMAGED (WORN, GOUGED, TORN, AND DISCOLORED). THE PATELLAR IMPLANT IS WORN WITH MATERIAL MISSING/TORN AWAY AROUND HALF OF THE PERIPHERAL EDGE. SOME BONE CEMENT REMAINS ARE STILL AFFIXED TO THE BACKSIDE OF THE PATELLAR IMPLANT; THE THREE PEGS WERE SAWN OFF. DIMENSIONAL ANALYSIS OF THE RETURNED IMPLANTS PASSED WHERE MEASURED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. PER THE INSTRUCTIONS FOR USE OF THE IMPLANTS, PAIN, AND LOOSENING OF THE PROSTHETIC KNEE COMPONENTS ARE KNOWN POTENTIAL ADVERSE EFFECTS ASSOCIATED WITH THE TKA PROCEDURE. THIS NEW INFORMATION DOES NOT AFFECT THE PREVIOUSLY COMPLETED INVESTIGATION. 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 WAS REPORTED THAT THE PATIENT IS EXPERIENCING KNEE PAIN.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT'S SURGEON HAS RECOMMENDED REVISION SURGERY DUE TO LOOSENING OF THE COMPONENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO UNKNOWN REASONS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS-FLEX FEMORAL COMPONENT NJL ZIMMER INC 60930940

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O NEXGEN LPS-FLEX ARTICULAR SURFACE WITH LOCKING| SCREW: CATALOG #00596404017, LOT #60489310| MANUFACTURED AT ZIMMER (B)(4)| CATALOG #00598004701, LOT #60489310| NEXGEN STEMMED TIBIAL COMPONENT: