BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE INSTRUMENT

    MDR report key: 8608820 · Received May 14, 2019

    Report

    Report Number
    1818910-2019-93414
    Event Type
    Injury
    Date Received
    May 14, 2019
    Date of Event
    April 11, 2019
    Report Date
    April 23, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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). NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. 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. DEVICE HISTORY LOT =NULL. DEVICE HISTORY BATCH = NULL. DEVICE HISTORY REVIEW =NULL. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). 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

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

    Description of Event or Problem · 1

    IMPLANTED ON (B)(6) 2019 DIAPHYSEAL TUMOR PROSTHESIS. A USER ERROR IS EXCLUDED BY THE CO-OPERATING, LEADING PHYSICIAN. DURING THE OPERATION 2 MA OF THE IMPLANT COMPANY WERE PRESENT, UNDER WHOSE GUIDANCE SURGERY WAS OPERATED. THERE WERE DIFFICULTIES INTRAOPERATIVELY, WHICH PROLONGED THE OP AND IN THE MEANTIME THE DANGER EXISTED THAT AN IATROGENIC FRACTURE WAS PROVOKED IN THE DIFFICULT REMOVAL OF THE TRIAL IMPLANT. (REMOVAL TOOLS WERE NOT AVAILABLE). LIKEWISE, THE ROTATION AFTER CEMENTATION CAN NO LONGER BE INFLUENCED. THE PROSTHESIS OFFERS, IN CONTRAST TO OTHER ALTERNATIVES, NO ANTI-ROTATION. HIGHER LOOSENING RATES CAN RESULT (NO LOCKING SCREW OR SIMILAR). SUPPLEMENT MVV: MATERIAL STILL IMPLANTED, IS THEREFORE NOT AVAILABLE FOR EXAMINATION. SO FAR, HOWEVER, NO CONSEQUENCES FOR THE PAT DETECTED. PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400894 UNKNOWN KNEE INSTRUMENT KNEE INSTRUMENT JWH DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention