BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SP*2 FEMORAL IMPACTOR

    MDR report key: 8633392 · Received May 22, 2019

    Report

    Report Number
    1818910-2019-94319
    Event Type
    Malfunction
    Date Received
    May 22, 2019
    Date of Event
    May 6, 2019
    Report Date
    May 6, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    HWA
    UDI-DI
    10603295247203
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY ORTHOPAEDICS, INC. (B)(4). PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITHOUT THE DEVICE TO EXAMINE. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. 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 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

    (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

    IT WAS REPORTED THAT TWO SEPARATE SIGMA SPECIALIST FEMORAL IMPACTORS BREAK RECENTLY. NEITHER ONE CAUSE AN ISSUE IN THE CASE AND WERE ABLE TO FIND A STERILE REPLACEMENT QUICKLY SO THERE WAS NO DELAY WITH THE CASES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLACK IMPACTION TIP CAME OFF THE METAL BASE THAT ATTACHES TO THE UNIVERSAL HANDLE, AND THE BLACK PORTION WAS STRIPPED AND THEREFORE THE METAL PORTION COULD NOT BE REATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424735 SP*2 FEMORAL IMPACTOR KNEE INSTRUMENT : IMPACTORS HWA DEPUY ORTHOPAEDICS, INC. 1818910 NA 10603295247203

    Patients

    Seq Age Sex Outcome Treatment
    1