BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11/13 S-ROM 40MM M SPEC+6

    MDR report key: 3914013 · Received July 3, 2014

    Report

    Report Number
    1818910-2014-22658
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    December 9, 2013
    Report Date
    August 4, 2014
    Manufacturer
    DEPUY INTL., LTD - 8010379
    Product Code
    LPH
    PMA / PMN Number
    PK060031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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

    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 AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS PRODUCT WAS REPORTED IN ERROR. NO PATIENT DEATH, SERIOUS INJURY OR EVIDENCE OF REPORTABLE PRODUCT MALFUNCTION OCCURRED. 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

    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.

    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. 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

    UPDATE 2/23/16, 2/24/16, 3/2/16, 3/8/16 MEDICAL RECORDS RECEIVED. MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. MEDICAL RECORDS REPORTED PATIENT HAD STIFFNESS AND RIGHT LEG WAS LONGER THAN LEFT AND HAD DECREASED FUNCTION OF HIP. REVISION SURGICAL REPORT NOTED THICK SANGUINOUS FLUID WITH BROWN HUE, BROWNISH TISSUE AND LOCAL TISSUE REACTION. LAB RESULTS FOR METAL IONS WERE LESS THAN 7 PARTS PER BILLION. THE COMPLAINT WAS UPDATED ON: MAR 10, 2016.

    Description of Event or Problem · 1

    UPDATE REC'D 8/4/2014- PFS AND MEDICAL RECORDS RECEIVED. PART/LOT WAS PROVIDED. AFTER REVIEW OF THE MEDICAL RECORDS THE REVISION OPERATIVE NOTE INDICATED THE CUP WAS REVISED, BUT THERE WAS NOT MENTION OF LOOSENING OR MALPOSITIONING SO IT IS NOT BEING REPORTED AT THIS TIME. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION AND A POPPING/SNAPPING SENSATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390943 11/13 S-ROM 40MM M SPEC+6 HIP FEMORAL HEAD LPH DEPUY INTL., LTD - 8010379 2332389

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention