BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA H CEMENTLESS STEM #2 STD

    MDR report key: 4743168 · Received April 23, 2015

    Report

    Report Number
    3005180920-2015-00066
    Event Type
    Injury
    Date Received
    April 23, 2015
    Report Date
    May 22, 2015
    Product Code
    MEH
    PMA / PMN Number
    K082792
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2015: LOT 052053: (B)(4) STEMS PRODUCED AND RELEASED ON (B)(6) 2006. EXPIRATION DATE: 01/31/2011. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 41 STEMS OF THE LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR ISSUE. LOT 051147: (B)(4) LINERS PRODUCED AND RELEASED ON (B)(6) 2005. EXPIRATION DATE: 08/31/2010. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) LINERS OF THE LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR ISSUE. LOT 051514: 50 HEADS PRODUCED AND RELEASED ON (B)(6) /2006. EXPIRATION DATE: 11/30/2010. ALL PARAMETERS IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF THE PRODUCTION. TO DATE, (B)(4) HEADS OF THE LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR ISSUE. FURTHER INVESTIGATION IS INCLUDED INTO ATTACHMENT 1.

    Additional Manufacturer Narrative · 1

    ON MARCH 24, 2015 WE RECEIVED THE COMMUNICATION THAT THE CODES AND LOTS OF THE STEM AND OF THE LINER PREVIOUSLY RECEIVED WERE WRONG: THE CORRECT INFORMATION IS UPDATED. IT WAS ALSO CONFIRMED THAT THE STEM WILL NOT BE RETURNED BACK. BATCH REVIEW ON THE CORRECT LOTS PERFORMED ON MAY 15, 2015: LOT 051323: (B)(4) STEMS MANUFACTURED AND RELEASED ON 26 OCTOBER 2005. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE STEMS OF THE LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. LOT 051148: (B)(4) LINERS MANUFACTURED AND RELEASED ON NOVEMBER 17, 2005. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) LINERS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269026 QUADRA H CEMENTLESS STEM #2 STD CEMENTLESS FEMORAL STEM, MEH, LZO MEH 01.12.032 051323

    Patients

    Seq Age Sex Outcome Treatment
    1