BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURAL-KNEE II STEMMED TIBIAL BASEPLATE

    MDR report key: 2263350 · Received September 21, 2011

    Report

    Report Number
    1822565-2011-02121
    Event Type
    Injury
    Date Received
    September 21, 2011
    Date of Event
    July 25, 2011
    Report Date
    April 6, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK936159
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO PRODUCT OR X-RAYS WERE RETURNED FOR REVIEW. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, THE COMMON CLINICAL PRESENTATION SUGGESTS THAT THE EVENT IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION ACTION FOR IN 2007. THIS CORRECTIVE ACTION INVOLVED ENHANCING THE LABELING FOR THE NATURAL KNEE II KNEE SYSTEM. REFERENCE MDR 1822565-2006-00284 FOR ADDITIONAL INFORMATION REGARDING THE CORRECTIVE ACTION TAKEN. EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS FOR THE TIBIAL COMPONENT DID NOT FIND ANY DEVIATIONS OR ANOMALIES. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE OTHER DEVICES WAS NOT POSSIBLE AS LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT. A PRODUCT HISTORY SEARCH IDENTIFIED NO OTHER COMPLAINTS FOR THE PART AND LOT COMBINATION OF THE TIBIAL COMPONENT. A PRODUCT HISTORY SEARCH FOR RELATED COMPLAINTS COULD NOT BE CONDUCTED FOR THE REMAINING COMPONENTS. SURGICAL NOTES 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.

    Additional Manufacturer Narrative · 1

    OTHER DEVICES USED: CATALOG #620009809, NATURAL-KNEE II SYSTEM CONGRUENT TIBIAL INSERT, LOT #1327935. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING AMENDED TO REFLECT CHANGES. OTHER DEVICES USED: CATALOG #620009811, NATURAL-KNEE II SYSTEM CONGRUENT TIBIAL INSERT, LOT #1327935. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CONCOMITANT MEDICAL PRODUCTS - NATURAL-KNEE II METAL BACKED PATELLA COMPONENT CATALOG# 6200-01-103, LOT# 1249137, NATURAL-KNEE II CONGRUENT TIBIAL INSERT CATALOG# 6200-09-811, LOT# 1327935, NATURAL-KNEE II SINTERLOCK POROUS COATED FEMORAL COMPONENT CATALOG# 6212-00-040, LOT# 1328609. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE TIBIAL COMPONENT DID NOT IDENTIFY ANY DEVIATIONS OR ANOMALIES THE DEVICE HISTORY RECORDS FOR THE ARTICULAR SURFACE AND RECEIVING INSPECTION REPORT WERE REVIEWED AND NO DEVIATIONS OR ANOMALIES WERE IDENTIFIED. THESE DEVICES ARE USED FOR TREATMENT. THE PRIMARY SURGICAL NOTES STATE THAT THE PATIENT UNDERWENT LEFT TKA TO TREAT SEVERE OSTEOARTHRITIS. INTRA-OPERATIVELY SEVERE TRICOMPARTMENTAL DEGENERATIVE OSTEOARTHRITIC CHANGES WERE NOTED WITH DEFICIENT ANTERIOR CRUCIATE LIGAMENT. THE POSTERIOR CRUCIATE LIGAMENT WAS INTACT AND PRESERVED. THE TIBIA AND FEMUR WERE CUT AND THE TRIAL COMPONENTS INSERTED. THE KNEE WAS TRACKED THROUGH A FULL RANGE OF MOTION, LIGAMENTS WERE BALANCED IN FLEXION AND EXTENSION. THE PATELLA WAS CUT AND A PATELLAR COMPONENT WAS IMPLEMENTED USING A PRESS FIT TECHNIQUE. SIMILARLY, BOTH THE FINAL TIBIAL AND FEMORAL COMPONENTS WERE IMPLEMENTED; TWO CANCELLOUS BONE SCREWS WERE ALSO INSERTED PROXIMALLY FOR FURTHER PURCHASE OF THE TIBIAL COMPONENT. THE KNEE TRACKED THROUGH THE FULL RANGE OF MOTION, THE LIGAMENTS WERE BALANCED AND THE PATELLAR TRACKING WAS MIDLINE. THE REVISION SURGICAL NOTES STATE THAT THE PATIENT UNDERWENT REVISION OF THE LEFT TKA THIRTEEN YEARS POST-IMPLANTATION BECAUSE OF A FAILURE CAUSED BY THE POLY BEARING WEAR CREATING A LARGE CYST IN THE TIBIA, AND EARLY LOOSENING OF THE TIBIAL COMPONENT. INTRA-OPERATIVELY, THERE WERE SIGNIFICANT CHANGES WITH POLY BEARING WEAR, A MARKED AMOUNT OF SYNOVIAL REACTION AND SCAR TISSUE IN THE SUPRAPATELLAR POUCH AND MEDIAL AND LATERAL RECESSES. EROSIVE CHANGES IN THE FEMUR TRIGGERED THE REMOVAL OF THE FEMORAL COMPONENT. THE TIBIAL COMPONENT WAS REMOVED AND A LARGE CYSTIC AREA WAS PRESENT IN THE PROXIMAL TIBIA. THE CLINICAL PRESENTATION SUGGESTS THAT THE EVENT IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTIVE ACTION IN 2007. THIS CORRECTIVE ACTION INVOLVED ENHANCING THE LABELING FOR THE NATURAL KNEE II KNEE SYSTEM TO USE ARTICULAR SURFACES MADE OF HIGHLY CROSSLINKED POLYETHYLENE WITH THE POROUS N-K II TIBIAL BASEPLATES IMPLANTED WITHOUT BONE CEMENT AND WITH SUPPLEMENTAL SCREW FIXATION. THEREFORE, THE ROOT CAUSE IS A PREVIOUSLY ADDRESSED PACKAGING, LABEL, OR INSTRUCTION ISSUE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE RETURNED DEVICES ALL EXHIBIT SIGNS OF WEAR ON ALL SURFACES INCLUDING SCRATCHES IN THE POLISHED SURFACE OF THE FEMORAL COMPONENT, AND THERE IS FOREIGN MATERIAL IN THE CSTI COATED SURFACES OF THE FEMORAL, TIBIAL AND PATELLAR COMPONENTS. THE ARTICULAR SURFACE SHOWS WEAR AND AT LEAST ONE GOUGE ON THE CONDYLAR SURFACE, AND WEAR AND SCRATCHES ON THE INFERIOR SURFACE. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED PAIN FOR A COUPLE OF YEARS AND THAT A CYST FORMED AROUND THE BONE SCREWS IN THE TIBIAL BASEPLATE. IMPLANTS WERE REMOVED, BONE GRAFT PACKED IN TIBIA AND NEXGEN LCCK WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATURAL-KNEE II STEMMED TIBIAL BASEPLATE JWH ZIMMER, INC. 1332067

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention CATALOG #620009809, LOT #UNK| NATURAL-KNEE II SYSTEM CONGRUENT TIBIAL INSERT,| NATURAL-KNEE II SYSTEM SINTERLOCK POROUS COATED| CATALOG #620001103, LOT #UNK| FEMORAL COMPONENT, CATALOG #621200040, LOT #UNK