BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*SLEEVE PRX ZTT, 16F-LRG

    MDR report key: 2911563 · Received January 11, 2013

    Report

    Report Number
    1818910-2013-00811
    Event Type
    Injury
    Date Received
    January 11, 2013
    Report Date
    June 5, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    K934412
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT HAS BEEN UPDATED BECAUSE IT WAS REPORTED THAT THE PATIENT WAS REVISED ON (B)(6) 2013 TO ADDRESS THIGH PAIN. THE STEM WAS LOOSE. PART AND LOT INFORMATION FOR THE STEM HAS BEEN ADDED. 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.

    Additional Manufacturer Narrative · 1

    CORRECTION: MANUFACTURING FACILITY: (B)(4).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 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). ADDED: EXPIRY DATE.

    Description of Event or Problem · 1

    THE COMPLAINT HAS BEEN UPDATED BECAUSE IT WAS REPORTED THAT THE PATIENT WAS REVISED ON (B)(6) 2013 TO ADDRESS THIGH PAIN. THE STEM WAS LOOSE. PART AND LOT INFORMATION FOR THE STEM HAS BEEN ADDED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: ON OR ABOUT (B)(6) 2010, PATIENT WAS IMPLANTED WITH A DEPUY PINNACLE MOM HIP IMPLANT ON HER LEFT SIDE. PATIENT EXPERIENCED PAIN, WEAKNESS, DIFFICULTY WITH SIMPLE DAILY ACTIVITIES AND WORK, AND ELEVATED LEVELS OF METAL IONS IN HER BLOOD STREAM. THERE IS NO MENTION OF REVISION SURGERY. UPDATE: (B)(4) 2012 - LITIGATION PAPERS RECEIVED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. UPDATE: (B)(4) 2012 - LITIGATION PAPERS RECEIVED. IN ADDITION TO THE PREVIOUSLY REPORTED ALLEGATIONS, IT IS ALSO ALLEGED THAT THE PATIENT SUFFERS FROM A POPPING/SNAPPING SENSATION. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. UPDATE: (B)(4) 2012 - PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS INDICATE THAT THE PATIENT SUFFERED A FRACTURE AT THE NECK OF THE TROCHANTER UPON IMPACTION OF THE SLEEVE. RECORDS ARE AVAILABLE FOR FURTHER REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18948 S-ROM*SLEEVE PRX ZTT, 16F-LRG DEPUY SLEEVE LPH DEPUY ORTHOPAEDICS INC US 2925265

    Patients

    Seq Age Sex Outcome Treatment
    1 Other