BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM M HEAD 36MM +0

    MDR report key: 2886305 · Received December 26, 2012

    Report

    Report Number
    1818910-2012-22994
    Event Type
    Injury
    Date Received
    December 26, 2012
    Report Date
    November 26, 2012
    Manufacturer
    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE
    Product Code
    LPH
    PMA / PMN Number
    K120599
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    **UPDATE** 10/20/2011 (RECD BY CQ ON (B)(6) 2012) - AMENDED COMPLAINT WAS RECEIVED FROM LEGAL. ALTHOUGH THE PATIENT'S DEVICE WAS ORIGINALLY REPORTED AS ASR, IT HAS BEEN DISCOVERED THAT THE PATIENT HAD PINNACLE DEVICES. THE COMPLAINT HAS BEEN UPDATED TO REFLECT THIS CHANGE. THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. 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. **UPDATE** 11/26/2012 - MEDICAL RECORDS RECEIVED. PART/LOT INFORMATION WAS IDENTIFIED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD CHANGE THE INVESTIGATION. RECORDS ARE AVAILABLE ON DISC IF NEEDED FOR FURTHER REVIEW. PATIENT HEIGHT IS (B)(6). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR THE REPORTED PART AND LOT CODE COMBINATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE CORRECTIVE ACTION WAS NOT ESTABLISHED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. 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. 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

    LITIGATION PAPERS ALLEGE THE PATIENT IS EXPERIENCING ACHING AND PAIN IN LEG AND HIP, DIFFICULTY WALKING, RUNNING AND PERFORMING OTHER ACTIVITIES. IT IS FURTHER REPORTED HE WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT. (B)(6). **UPDATE** (B)(4) 2011 (RECD BY CQ ON (B)(4) 2012) - AMENDED COMPLAINT WAS RECEIVED FROM LEGAL. ALTHOUGH THE PATIENTS DEVICE WAS ORIGINALLY REPORTED AS ASR, IT HAS BEEN DISCOVERED THAT THE PATIENT HAD PINNACLE DEVICES. THE COMPLAINT HAS BEEN UPDATED TO REFLECT THIS CHANGE. **UPDATE** (B)(4) 2012 - MEDICAL RECORDS RECEIVED. PART/LOT INFORMATION WAS IDENTIFIED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD CHANGE THE INVESTIGATION. RECORDS ARE AVAILABLE ON DISC IF NEEDED FOR FURTHER REVIEW. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S-ROM M HEAD 36MM +0 TOTAL HIP REPLACEMENT LPH IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE 2841199

    Patients

    Seq Age Sex Outcome Treatment
    1 Other