BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERF CONS TIB BEARING 12MM S

    MDR report key: 2821488 · Received November 6, 2012

    Report

    Report Number
    0009610576-2012-00024
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 8, 2012
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    JWH
    PMA / PMN Number
    PK936274
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING HISTORY RECORDS SHOWS THAT THE PRODUCT HAS BEEN MANUFACTURED ACCORDING TO BIOMET (B)(4)'S PRE-DEFINED SPECIFICATIONS. BIOMET (B)(4) IS THE SUB CONTRACTOR OF THIS PRODUCT. TEN PRODUCTS HAVE BEEN MANUFACTURED IN JUNE 2009 IN BIOMET (B)(4) FACILITY. THE ANALYSIS OF THE PRODUCT SHOWS THAT THE SCREW IS COMPLIANT WITH SPECIFICATION. THE INSERT IS DAMAGED SO IT WAS NOT POSSIBLE TO FULLY ANALYSE IT. THE SIZE OF THE IMPLANT IS COMPLIANT WITH THE REFERENCE AND DESIGNATION OF THE PRODUCT. THE MANUFACTURING HISTORY RECORD OF THE INLAY AND THE SCREW PACKAGED WITH THE INLAY SHOWS THAT THE PRODUCTS WERE MANUFACTURED ACCORDING TO BIOMET (B)(4) PREDEFINED SPECIFICATION. THE ANALYSIS OF THE PRODUCTS RETURNED (INLAY AND SCREW) DID NOT SHOW ANY ABNORMALITY. THE EXACT ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. ITEM WAS NOT RETURNED TO THE MANUFACTURER. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT KNEE PROCEDURE IN (B)(6) 2011. REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 DUE TO THE LOCKING SCREW COMING LOOSE. SCREW WAS REMOVED AT TIME OF REVISION. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERF CONS TIB BEARING 12MM S PROSTHESIS, KNEE JWH BIOMET SPAIN, S.L. N/A 0000446888

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R