BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AML 15.0 MMA 6.3 5/8 STD 12/14

    MDR report key: 3234775 · Received July 18, 2013

    Report

    Report Number
    1818910-2013-21588
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    August 22, 2012
    Report Date
    June 27, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK953694
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE LOT CODE ZX6KE1000. A SEARCH OF THE COMPLAINT DATABASE FINDS ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODES 2072399 AND 2083820 SINCE THEIR RELEASE FOR DISTRIBUTION; HOWEVER, A PREVIOUS REVIEW OF THE DEVICE HISTORY RECORDS 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.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER WPC (B)(4). REASON FOR ORIGINAL COMPLAINT.- LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, AND LIMITED MOBILITY. DOI: (B)(6) 2006 - DOR: NONE REPORTED (LEFT SIDE). *PATIENT IS A RESIDENT OF (B)(6). **UPDATE** (B)(4) 2012- MEDICAL RECORDS AND PATIENT FACT SHEET RECEIVED. PART/LOT WAS PROVIDED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE MDR DECISION. RECORDS ARE AVAILABLE ON THE L:\DRIVE IF NEEDED FOR FURTHER REVIEW. **UPDATE** (B)(4) 2013- UPON MEDICAL RECORD REVIEW BY A MEDICAL PROFESSIONAL, A CALCAR CRACK WAS DISCOVERED. THE STEM HAS NOW BEEN ADDED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332987 AML 15.0 MMA 6.3 5/8 STD 12/14 FEMORAL STEM LPH DEPUY ORTHOPAEDICS, INC. ZX6KE1000

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other