BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASPHERE M SPEC 11/13 36 +3

    MDR report key: 3003822 · Received March 14, 2013

    Report

    Report Number
    1818910-2013-13783
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    September 6, 2011
    Report Date
    September 11, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    PK082585
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS BEEN REOPENED DUE TO RECEIVING PART AND LOT NUMBER. DEPUY WILL NOTIFY THE FDA WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    UPDATE: (B)(6) 2013 - PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL. THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    CORRECTION: MANUFACTURING FACILITY: LEEDS 8010379 DEPUY INTL., LTD. / 1818910 DEPUY ORTHOPAEDICS, INC. / 8010379 DEPUY INTL., LTD. LEGAL CLAIM RECEIVED. IT IS ALLEGED THAT THE PATIENT SUFFERS FROM PAIN, A PSEUDOTUMOR, AND METAL ON METAL ISSUES. DOI: (B)(6) 2011- (B)(6) 2011 (LEFT HIP). UPDATE: 4/26/13 - LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES DISCOMFORT. PART AND LOT INFORMATION HAVE BEEN IDENTIFIED. DATE OF REVISION HAS BEEN UPDATED. THERE IS NO ADDITIONAL INFORMATION THAT WOULD AFFECT THE OUTCOME OF THIS INVESTIGATION. UPDATE: 9/11/2013 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS FOR LOT CODES 3216507 AND 3210257A DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE AND/OR DHR REVIEW 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 DETERMINE 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.

    Description of Event or Problem · 1

    LEGAL CLAIM RECEIVED. IT IS ALLEGED THAT THE PATIENT SUFFERS FROM PAIN, A PSEUDOTUMOR, AND METAL ON METAL ISSUES.**UPDATE: (B)(4) 2013 - LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES DISCOMFORT. PART AND LOT INFORMATION HAVE BEEN IDENTIFIED. DATE OF REVISION HAS BEEN UPDATED. THERE IS NO ADDITIONAL INFORMATION THAT WOULD AFFECT THE OUTCOME OF THIS INVESTIGATION.

    Description of Event or Problem · 1

    LEGAL CLAIM RECEIVED. IT IS ALLEGED THAT THE PATIENT SUFFERS FROM PAIN, A PSEUDOTUMOR, AND METAL ON METAL ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108030 ASPHERE M SPEC 11/13 36 +3 FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US 3210257A

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention