BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*SLEEVE PRX ZTT, 18B-LRG

    MDR report key: 3041264 · Received April 8, 2013

    Report

    Report Number
    1818910-2013-15067
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    LPH
    PMA / PMN Number
    PK934412
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. REASON FOR REVISION HAS NOT BEEN PROVIDED AND NO CONCLUSIONS REGARDING THE REPORTING CAN BE DRAWN. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE CUP, INSERT, AND STEM PRODUCT/LOT CODE COMBINATIONS. ONE OTHER REPORT IS FOUND AGAINST THE FEMORAL HEAD AND FEMORAL SLEEVE. IT IS NOT KNOWN IF THE REPORTS ARE SIMILAR AS NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO CUSTOMER QUALITY. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN IDENTIFIED. ADDENDUM ADDED 08-JUNE-15. INFORMATION RECEIVED FROM (B)(6). CLAIM RECEIVED. POSSIBLE REVISION OF PINNACLE MOM IMPLANTS. REASON NOT PROVIDED, REVISION NOT CONFIRMED. IMPLANTED IN 2005. UPDATE MAY 17 2013 - PATIENT CONSENT FORM RECEIVED WHICH CONTAINED DOI AND DOR DATE OF NOVEMBER 2011. COMPLAINT REOPENED - ADDITIONAL INFORMATION RECEIVED 20 APRIL 2015 - PATIENTS RIGHT SIDE WAS REVISED ON (B)(6) 2012 DUE TO PAIN - (B)(4). NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT 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

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. REASON FOR REVISION HAS NOT BEEN PROVIDED AND NO CONCLUSIONS REGARDING THE REPORTING CAN BE DRAWN. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE CUP, INSERT, AND STEM PRODUCT/LOT CODE COMBINATIONS. ONE OTHER REPORT IS FOUND AGAINST THE FEMORAL HEAD AND FEMORAL SLEEVE. IT IS NOT KNOWN IF THE REPORTS ARE SIMILAR AS NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO CUSTOMER QUALITY. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN IDENTIFIED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS BEEN REOPENED DUE TO RECEIVING NEW INFORMATION. DEPUY WILL NOTIFY THE FDA WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4).

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    POSSIBLE REVISION OF PINNACLE MOM IMPLANTS. REASON NOT PROVIDED, REVISION NOT CONFIRMED.

    Description of Event or Problem · 1

    UPDATE: APRIL 20, 2015 THE PATIENT WAS REVISED BECAUSE OF PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142788 S-ROM*SLEEVE PRX ZTT, 18B-LRG HIP FEMORAL STEM/SLEEVE LPH DEPUY IRELAND 9616671 1929440

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention