BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL AMT COLLAR SIZE 11

    MDR report key: 2142962 · Received June 23, 2011

    Report

    Report Number
    1818910-2011-11104
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 2011
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    KWA
    PMA / PMN Number
    K042992
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    **UPDATE - THIS IS A CLINICAL PATIENT, RECEIVED LOT INFORMATION FOR THE STEM. **UPDATE** 1/28/2013 - PATIENT SEEKING LEGAL ACTION. PFS AND MEDICAL RECORDS RECEIVED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. RECORDS ARE AVAILABLE ON THE L DRIVE IF NEEDED FOR FURTHER REVIEW. THE STEM ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THIS DEVICE HISTORY RECORD DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. 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.

    Additional Manufacturer Narrative · 1

    CONCLUSION AND JUSTIFICATION STATUS FOR MDR: A COMPLAINT DATABASE SEARCH DID FIND ADDITIONAL RELATED REPORTS AGAINST THE METAL LINER AND/OR FEMORAL HEAD PRODUCT CODE AND LOT NUMBER COMBINATION(S). HOWEVER; A REVIEW OF THE DEVICE HISTORY RECORD(S) ASSOCIATED WITH THIS COMPLAINT WAS NOT REQUIRED PER WI-3430. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO ADDITIONAL RELATED REPORTS AGAINST THE REMAINING PRODUCT CODE/LOT CODE COMBINATION(S). 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS PRODUCT WAS FOUND TO BE NONCONTRIBUTING TO THE EVENT. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    ADDED DESCRIBE EVENT OR PROBLEM, RELEVANT TESTS/LAB DATA, AND REPORT SOURCE. DEPUY STILL 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

    (B)(4).

    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.

    Description of Event or Problem · 1

    UPDATE REC'D 2/11/2014-PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS/OPERATIVE NOTES A CORRECT PART NUMBER WAS GIVEN FOR THE CUP. THE RECORDS CONFIRMED LOOSENING OF THE CUP. THE STEM WAS ALSO PREVIOUSLY REPORTED FOR LOOSENING, BUT THE RECORDS CONFIRMED THE STEM WAS WELL FIXED. THE STEM IS NOW BEING CHANGED TO NONCONTRIBUTING. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION.

    Description of Event or Problem · 1

    UPDATE: 10/04/2016 MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THERE IS NO ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING INVESTIGATION. THE METAL ION LEVELS PROVIDED WERE AT NON-REPORTABLE LEVELS.

    Description of Event or Problem · 1

    UPDATE AD (B)(4) 2018: COM-040701 HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS. PPF ALLEGES METAL WEAR. ADDED LAWYER AND LAW FIRM. DOI: (B)(6) 2008 - DOR: MAY 24, 2011 (LEFT HIP). PATIENT IS BILATERAL. SEE (B)(4) FOR THE RIGHT HIP. (B)(4) FOR THE SECOND REVISION.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS METAL-ON-METAL DISEASE, OSTEOLYSIS CAUSING LOOSENING OF THE CUP AND PROXIMAL LOOSENING OF THE STEM, WITH SEVERE LIQUID BUILDUP AND PRESSURE. THE STEM WAS NOT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORAIL AMT COLLAR SIZE 11 CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM KWA DEPUY FRANCE SAS - 3003895575 NA 2549726

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention