BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SHAPEMATCH CUTTING GUIDE

    MDR report key: 8894900 · Received August 14, 2019

    Report

    Report Number
    0002249697-2019-02851
    Event Type
    Injury
    Date Received
    August 14, 2019
    Date of Event
    September 12, 2012
    Report Date
    August 14, 2019
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    Removal / Correction Number
    2249697-11/19/12-013-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS DEPARTMENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME DUE TO THE ONGOING LITIGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. VOLUNTARY RECALL RA 2012-171 WAS INITIATED FOR US SHAPEMATCH CUTTING GUIDES DUE TO THE POTENTIAL RISKS ASSOCIATED WITH THESE DEVICES. THIS REPORT IS CONSIDERED TO BE UNDER THE SCOPE OF THIS RECALL. AS A RESULT OF AN INTERNAL NONCONFORMANCE THE FOLLOWING ROOT CAUSES WERE IDENTIFIED: INADEQUATE DESIGN CONTROLS. INADEQUATE USER TRAINING. INSUFFICIENT QUALITY CONTROL MEASURES. ALL PRODUCT WAS QUARANTINED, REMOVED FROM THE MARKET AND ARE NO LONGER MANUFACTURED OR SOLD, THEREFORE, NO FURTHER ACTION IS REQUIRED. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATE THAT DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ATTORNEY, THAT THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2012 WHERE SHAPEMATCH CUTTING GUIDES WERE USED AND A TRIATHLON KNEE SYSTEM WAS IMPLANTED. IT IS UNKNOWN IF THE PATIENT HAS UNDERGONE REVISION SURGERY AT THIS TIME. UPDATE VIA CONVERSATION WITH LEGAL DEPARTMENT JULY 30, 2019: THE PATIENT HAS COMPLAINED OF PAIN BUT DOES NOT WANT TO PURSUE SURGICAL INTERVENTION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688037 UNKNOWN SHAPEMATCH CUTTING GUIDE PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other