BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM M HEAD 36MM +3

    MDR report key: 3815208 · Received May 16, 2014

    Report

    Report Number
    1818910-2014-18928
    Event Type
    Injury
    Date Received
    May 16, 2014
    Date of Event
    March 20, 2014
    Report Date
    October 17, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LPH
    PMA / PMN Number
    PK120599
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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 COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.(B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY 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

    (B)(4). NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE 2371220 LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND ADDITIONAL REPORTS AGAINST THE 2313642 AND 2250123 LOT CODES. 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. 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. 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

    LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT AND METALLOSIS.

    Description of Event or Problem · 1

    UPDATE REC'D 10/17/2014- PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED PAIN, INCREASED METAL IONS, AND METAL DEBRIS THAT APPEARED TO BE COMING FROM THE TRUNNION AND MORRIS TAPER. THERE WAS NO MENTION OF METALLOSIS AS LITIGATION ALLEGED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294301 S-ROM M HEAD 36MM +3 HIP FEMORAL HEAD LPH DEPUY ORTHOPAEDICS, INC. 1818910 2250123

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention