BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE TIBIAL TRAY

    MDR report key: 10000893 · Received April 27, 2020

    Report

    Report Number
    1818910-2020-11331
    Event Type
    Injury
    Date Received
    April 27, 2020
    Date of Event
    March 1, 2012
    Report Date
    April 20, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE(S) WAS NOT PROVIDED. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THE LITERATURE ARTICLE ENTITLED ¿IN VIVO TESTING OF KNEE STABILITY AFTER ROTATING-HINGE TOTAL KNEE ARTHROPLASTY: A COMPARISON OF 2 KNEE SYSTEMS¿, WRITTEN BY JOERG FRIESENBICHLER, MD, ET AL, PUBLISHED ON THE ORTHOSUPERSITE.COM, MARCH 2012, VOL 35, NUMBER 3, WAS REVIEWED. THE PURPOSE OF THE STUDY WAS TO COMPARE IN VIVO STABILITY AND FUNCTIONAL OUTCOME OF THESE ROTATING-HINGE PROSTHESES. DEPUY PRODUCTS USED: LIMB PRESERVATION SYSTEM AND S-ROM NOILES. BETWEEN (B)(6) 2003 AND (B)(6) 2008, 25 PATIENTS UNDERWENT TKA USING THE LPS/MBT OR THE S-ROM NOILES ROTATING-HINGE PROSTHESIS. NO NOTE OF PATELLAR RESURFACING. ADVERSE EVENTS: FIVE DISLOCATIONS OCCURRED IN THREE PATIENTS. ONE DISLOCATION WAS TRAUMATIC, ONE PROSTHESIS DISLOCATED DUE TO A LOOSENED FEMORAL COMPONENT, AND THREE PROSTHESES DISLOCATED AFTER FRACTURE OF THE METAL YOKE INSIDE THE HINGED TIBIAL INSERT. ALL YOKE FRACTURES OF THE LPS/MBT HINGED INSERT OCCURRED AT THE TRANSITION ZONE FROM THE CONICAL TO THE CYLINDRICAL PART. CONSEQUENTLY, THE HINGED TIBIAL INSERT WAS CHANGED IN ALL CASES, AND THE EXTENSOR MECHANISM WAS RECONSTRUCTED IN TWO. AFTER A SECOND DISLOCATION DUE TO A YOKE FRACTURE IN ONE PATIENT, THE MANUFACTURER MODIFIED THE METAL YOKE, AND NO FURTHER COMPLICATIONS OCCURRED DURING A FOLLOW-UP PERIOD OF NINE MONTHS. THERE WERE ALSO TWO PATIENTS WITH LPS/MBT DEVICE WHOSE ACTIVE AND PASSIVE FLEXION WAS LIMITED TO 30 AND 50 DEGREES DUE TO EXTENSIVE SOFT TISSUE COMPROMISE FOLLOWING TUMOR RESECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463594 UNKNOWN KNEE TIBIAL TRAY KNEE TIBIAL TRAY JWH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention