BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX58OD

    MDR report key: 3172441 · Received June 17, 2013

    Report

    Report Number
    1818910-2013-18991
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    March 24, 2017
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    K003523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    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. UDI: (B)(4).

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. 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. 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. 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 (3/24/2017) MEDICAL RECORDS RECEIVED. RIGHT HIP REVISED FOR PAIN AND POSSIBLE INFECTION. REVISING SURGEON HAD PERFORMED A HIP ASPIRATION PRIOR TO SURGERY WHICH REVEALED A SUSPICIOUS, PURULENT APPEARING MATERIAL; BUT THIS SHOWED NO INFECTION OR MALIGNANCY, ONLY SHOWING EVIDENCE OF INFLAMMATION AND SUPPURATIVE DEBRIS. OPERATIVE TECHNIQUE REVEALED "WHAT APPEARED TO BE, AN ABSCESS, AND THERE WAS CLOUDY FLUID IN THIS AREA". IDENTIFIED "BURNISHING" OF THE STEM MORSE TAPER, AS WELL AS BLACKISH MATERIAL AROUND THE BASE OF THE FEMORAL HEAD. THE STEM AND CUP WERE WELL FIXED, AND THE METAL LINER "WAS INTACT". FEMORAL HEAD REVISED. FROZEN SECTION SENT INTRAOP DID NOT IDENTIFY ANY INFECTION, AS NO FURTHER INFORMATION IS AVAILABLE, THE QUESTION OF INFECTION APPEARS TO BE NEGATIVE BASED ON THE PRIOR ASPIRATION AND FROZEN SECTION RESULTS. IF ADDITIONAL INFORMATION IS PROVIDED TO DISPUTE THAT, THEN INFECTION WILL BE REVISITED. CORROSION:TAPER ADDED TO COMPLAINT. STEM ADDED TO COMPLAINT. PROD/LOT UPDATED.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, AND DIFFICULTY AMBULATING. IT WAS ALSO ALLEGED THAT THE PATIENT UNDERWENT A FEMORAL HEAD REVISION ON (B)(6) 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272823 PINNACLE MTL INS NEUT36IDX58OD METAL LINER KWA DEPUY ORTHOPAEDICS INC US 1078164

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other