BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPS/OSS 5CM TPR ADAPT W/OSS SC

    MDR report key: 4093758 · Received September 16, 2014

    Report

    Report Number
    0001825034-2014-07741
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 18, 2014
    Report Date
    November 20, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KRO
    PMA / PMN Number
    PK041352
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH AND TO CORRECT INFORMATION THAT WAS REPORTED IN ERROR ON THE INITIAL REPORT. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. IMPLANT DATE IS (B)(6) 2014. THE IMPLANT WAS NOT AVAILABLE DURING THE (B)(6) 2014 AS IT SHOULD HAVE BEEN; THEREFORE, ANOTHER REVISION OCCURRED ON (B)(6) 2014 WHEN THE IMPLANT WAS MADE AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. EVENT IS BEING REPORTED TO FDA ON MEDWATCH SINCE THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE OCCURRED AND A NECESSARY IMPLANT WAS NOT AVAILABLE. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND IF WARRANTED, FURTHER MEDWATCH REPORTS WILL BE SUBMITTED. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-07743).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON IN (B)(6) 2001. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014 DUE TO A FRACTURE UNDER THE STEM. DURING THE PROCEDURE, THE FEMORAL STEM WAS REMOVED AND IT WAS DISCOVERED THAT THE OSS/COMPRESS TAPER ADAPTER NECESSARY FOR THE REVISION WAS NOT AVAILABLE IN THE OPERATING ROOM. THE PROCEDURE WAS FINISHED USING A NAIL AND SPACERS. THE PATIENT WAS REVISED ON (B)(6) 2014 IN ORDER TO IMPLANT THE CORRECT PRODUCT COMPONENTS ONCE THE TAPER ADAPTER WAS MADE AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON IN (B)(6) 2001. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014 DUE TO A FRACTURE UNDER THE STEM. DURING THE PROCEDURE, THE FEMORAL STEM WAS REMOVED AND IT WAS DISCOVERED THAT THE OSS/COMPRESS TAPER ADAPTER NECESSARY FOR THE REVISION WAS NOT AVAILABLE IN THE OPERATING ROOM. THE PROCEDURE WAS FINISHED USING A NAIL AND SPACERS, HOWEVER, THE PATIENT WILL HAVE TO UNDERGO ANOTHER PROCEDURE IN ORDER TO IMPLANT THE CORRECT COMPONENTS. NO REVISION HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573138 CPS/OSS 5CM TPR ADAPT W/OSS SC PROSTHESIS, KNEE KRO BIOMET ORTHOPEDICS N/A 525060

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention