BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRS FEM W/MALE-FE TAPER 40 BD

    MDR report key: 3564658 · Received January 9, 2014

    Report

    Report Number
    0002249697-2014-00116
    Event Type
    Injury
    Date Received
    January 9, 2014
    Date of Event
    December 5, 2013
    Report Date
    December 5, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K952970
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS PROVIDED FOR DEVICES LISTED AS UNKNOWN IN THE INITIAL REPORT: CATALOG: 2481-3-040 DESCRIPTION: MRS FEM W/MALE-FE TAPER 40 BD LOT: UNKNOWN / INITIALLY REPORTED AS: UNKNOWN 40 MM BODY. CATALOG: 2481-8-010 DESCRIPTION: MRS FEM ROT HNGE LFT 65MM BOD LOT: UNKNOWN / INITIALLY REPORTED AS: UNKNOWN MRS DISTAL FEMUR. CATALOG: 64753933 DESCRIPTION: TIBIAL COMP KIN HINGE KNEE LOT: SKA6D / INITIALLY REPORTED AS: UNKNOWN LONG TIBIAL BEARING. CATALOG: 64753940 DESCRIPTION: KRH STANDARD AXLE LOT: LTBRI2A / INITIALLY REPORTED AS: UNKNOWN AXLE CORRECTED LOT INFORMATION: CATALOG: 64852460 DESCRIPTION: KRH DURATION BUSHING STANDARD LOT: LPTC083, CATALOG: 64854100 DESCRIPTION: KRH DURATION STANDARD BUMPER LOT: LPTC180.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN 40MM BODY. ADDITIONAL DEVICES LISTED IN THIS REPORT: -UNKNOWN MRS DISTAL FEMUR. -UNKNOWN LING TIBIAL BEARING. -UNKNOWN AXLE. CAT 6485-2-460, LOT LPTC154, DESCRIPTION: KRH DURATION BUSHING. CAT 6485-2-460, LOT LPTC068, DESCRIPTION: KRH DURATION BUSHING. CAT 6485-4-100, LOT UNKNOWN, DESCRIPTION: KRH DURATION STANDARD BUMPER. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. IT WAS NOTED THAT THE DEVICES ARE NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING PAIN INVOLVING AN MRS 40 MM BODY WAS REPORTED. THE EVENT WAS CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED MEDICAL RECORDS AND X-RAYS BY A CLINICAL CONSULTANT INDICATED: NO CLINICAL OR PAST MEDICAL HISTORY, NO OPERATIVE REPORTS, NO EXAMINATION OF EXPLANTED COMPONENTS, AND NO RESULTS OF THE CULTURES AND SENSITIVITIES ARE AVAILABLE FOR REVIEW. JUDGING BY THE DISTAL FEMORAL REPLACEMENT MODULAR TUMOR COMPONENTS AND THE USE IN THIS PATIENT, IT CAN BE ASSUMED THAT THE INITIAL SURGERY WAS A TUMOR SALVAGE PROCEDURE WITH HIGH RISK OF INFECTION AND LATE FATIGUE FAILURE. THE FACT THAT SHE HAS SURVIVED OVER TWENTY YEARS WITH THIS IMPLANT IS IMPRESSIVE. THE ADVENT OF LATE INFECTION HAS BEEN AGGRESSIVELY TREATED AND, IT APPEARS, SUCCESSFULLY SO. THERE ARE NO PROSTHETIC RELATED FACTORS THAT EITHER CAUSED OR WOULD HAVE PREVENTED THIS CLINICAL SITUATION. DEVICE HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS NO LOT ID INFORMATION WAS PROVIDED. COMPLAINT HISTORY REVIEW: BASED ON THE DEVICE IDENTIFICATION A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS NO LOT ID INFORMATION WAS PROVIDED. CONCLUSIONS: MEDICAL REVIEW INDICATES THERE ARE NO PROSTHETIC RELATED FACTORS THAT EITHER CAUSED OR WOULD HAVE PREVENTED THIS CLINICAL SITUATION. A CAPA TREND ANALYSIS CONDUCTED REGARDING PAIN INDICATES THAT PATIENT PAIN MAY RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PATIENT SEEN BY SURGEON WHO SUSPECTS THAT PATIENT IS INFECTED AGAIN. SURGERY IS SCHEDULED ON DEC 16 AND MORE WILL BE AVAILABLE. INFORMATION RECEIVED POST SURGERY 12/18/13: THE PATIENT WAS OPERATED ON (B)(6) 2013. PATIENT PHYSICAL INFORMATION REMAINS THE SAME. AT SURGERY, BIOPSY (FROZEN SPECIMEN) DID NOT SHOW ANY INFECTION. THE ANTIBIOTIC BEADS WERE REMOVED, THE TISSUE WAS DEBRIDED EXTENSIVELY. THE 40 MM BODY, MRS DISTAL FEMUR AND LONG TIBIAL BEARING IMPLANTED IN 1993 PLUS THE MRS PLASTIC BUSHINGS AND BUMPER IMPLANTED ON (B)(6) 2013 WERE REMOVED. A NEW GMRS 40 MM BODY EXTENSION, GMRS SMALL DISTAL FEMUR AND A NEW MRS LONG TIBIAL BEARING WERE INSERTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PATIENT SEEN BY SURGEON WHO SUSPECTS THAT PATIENT IS INFECTED AGAIN. SURGERY IS SCHEDULED ON (B)(6) AND MORE WILL BE AVAILABLE. INFORMATION RECEIVED POST SURGERY 12/18/13: THE PATIENT WAS OPERATED ON (B)(6) 2013. PATIENT PHYSICAL INFORMATION REMAINS THE SAME. AT SURGERY, BIOPSY (FROZEN SPECIMEN) DID NOT SHOW ANY INFECTION. THE ANTIBIOTIC BEADS WERE REMOVED, THE TISSUE WAS DEBRIDED EXTENSIVELY. THE 40 MM BODY, MRS DISTAL FEMUR AND LONG TIBIAL BEARING IMPLANTED IN 1993 PLUS THE MRS PLASTIC BUSHINGS AND BUMPER IMPLANTED ON (B)(6) 2013 WERE REMOVED. A NEW GMRS 40 MM BODY EXTENSION, GMRS SMALL DISTAL FEMUR AND A NEW MRS LONG TIBIAL BEARING WERE INSERTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PATIENT SEEN BY SURGEON WHO SUSPECTS THAT PATIENT IS INFECTED AGAIN. SURGERY IS SCHEDULED ON (B)(6) AND MORE WILL BE AVAILABLE. INFORMATION RECEIVED POST SURGERY (B)(6) 2013: THE PATIENT WAS OPERATED ON (B)(6) 2013. PATIENT PHYSICAL INFORMATION REMAINS THE SAME. AT SURGERY, BIOPSY (FROZEN SPECIMEN) DID NOT SHOW ANY INFECTION. THE ANTIBIOTIC BEADS WERE REMOVED, THE TISSUE WAS DEBRIDED EXTENSIVELY. THE 40 MM BODY, MRS DISTAL FEMUR AND LONG TIBIAL BEARING IMPLANTED IN IN1993 PLUS THE MRS PLASTIC BUSHINGS AND BUMPER IMPLANTED ON (B)(6) 2013 WERE REMOVED. A NEW GMRS 40 MM BODY EXTENSION, GMRS SMALL DISTAL FEMUR AND A NEW MRS LONG TIBIAL BEARING WERE INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17025 MRS FEM W/MALE-FE TAPER 40 BD PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention