BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTER-OP CUP

    MDR report key: 5077488 · Received September 15, 2015

    Report

    Report Number
    9613350-2015-01271
    Event Type
    Injury
    Date Received
    September 15, 2015
    Date of Event
    August 18, 2015
    Report Date
    August 18, 2015
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTER-OP CUP WAS MANUFACTURED BY ZIMMER (B)(4). ZIMMER (B)(4) WILL INVALIDATE THIS REPORT FROM THE SYSTEM AS ZIMMER (B)(4) IS NOT THE MANUFACTURER OF THIS PRODUCT. THIS PRODUCT WILL BE FURTHER INCLUDED IN THE EXISTING CASE (B)(4) FROM ZIMMER INC., (B)(4). THE CASE (B)(4) WILL FURTHER REPORT THE PRODUCT METASUL HEAD ONLY (MFR 9613350-2015-01272-001). PLEASE INVALIDATE THIS REPORT MFR 9613350-2015-01271 FROM YOUR SYSTEM. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW.AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT THE PATIENT RECEIVED AN UNKNOWN INTER-OP CUP ON AN UNKNOWN DATE. THE PATIENT EXPERIENCED A SURGICAL SITE INFECTION REQUIRING SURGICAL IRRIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607859 INTER-OP CUP INTER-OP METASUL ACETABULAR SYSTEM KWA ZIMMER GMBH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other