BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*SLEEVE PRX ZTT, 18F-XXL

    MDR report key: 2970175 · Received February 20, 2013

    Report

    Report Number
    1818910-2013-04010
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    December 19, 2011
    Report Date
    February 8, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    PK964412
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A WORLDWIDE COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE NEWLY ADDED SROM STEM AND SLEEVE PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOR THE UNKNOWN SROM STEM AND SLEEVE WAS NOT POSSIBLE AS THE PRODUCT AND LOT COMBINATIONS WERE NOT PROVIDED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS OTHER REPORTS AGAINST THE FEMORAL HEADS AND METAL INSERTS. PER PROCEDURE, THESE DEVICES ARE EXEMPT FROM DEVICE HISTORY RECORD REVIEW. OTHER REPORTS WERE FOUND AGAINST THE 2424693 AND 2019671 LOT CODES. PRODUCT CODE 563618, WORK ORDER 2424693 WAS MANUFACTURED ON 11 JULY 2007. 27 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. PRODUCT CODE 563620, WORK ORDER (B)(4) WAS MANUFACTURED ON 25 NOV 2005. 15 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. A SEARCH OF THE COMPLAINTS DATABASES AGAINST THE REMAINDER OF THE PRODUCT/LOT CODE COMBINATIONS FOUND NO OTHER REPORTS. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION MADE AVAILABLE. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS REVISED BILATERALLY TO ADDRESS SEVERE OSTEOLYSIS, LOOSENING OF THE CUP, AND METALLOSIS ON THE RIGHT SIDE, WITH METALLOSIS AND OSTEOLYSIS ON THE LEFT SIDE. (BOTH HIPS). THIS IS A CLINICAL PATIENT. **UPDATE** 2/8/2013 - PATIENT'S MEDICAL RECORDS WERE RECEIVED. RECORDS INDICATE UPON REVISION CORROSION WAS FOUND IN THE RIGHT HIP. STEM AND SLEEVE WERE ADDED TO THE COMPLAINT FOR THE RIGHT HIP. RECORDS ALSO INDICATE UPON REVISION.

    Description of Event or Problem · 1

    PPF ALLEGES PSEUDOTUMOR AND METAL WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73836 S-ROM*SLEEVE PRX ZTT, 18F-XXL SLEEVE LPH DEPUY ORTHOPAEDICS INC US 2218858

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention