BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT POR TAPER SZ5 STD OFF

    MDR report key: 3821890 · Received May 20, 2014

    Report

    Report Number
    1818910-2014-19138
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    December 21, 2011
    Report Date
    November 16, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    K001991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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 NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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

    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. 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).

    Description of Event or Problem · 1

    LITIGATION PAPERS RECEIVED. IT IS ALLEGED THAT THE PATIENT SUFFERED FROM PAIN, LIMITED MOBILITY, GRINDING SENSATIONS, AUDIBLE SQUEAKING, AND ELEVATED LEVELS OF COBALT CHROMIUM. UPDATE (B)(4) 2013- DER WAS RECEIVED WITH PART/LOT INFORMATION. UPDATE: (B)(4) 2012 - PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. PATIENT DEMOGRAPHICS ADDED. ON (B)(4) 2014 - X-RAYS CD RECEIVED AND PLACED IN FILE. X-RAYS MAY PERTAIN TO (B)(4). UPDATE REC'D (B)(4) 2012- PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS IT CONFIRMED METALLOSIS. IT ALSO STATED THERE WAS IMPINGEMENT OF THE ACETABULAR COMPONENT SO THE UCP AND STEM ARE NOW BEING REPORTED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: (B)(4) 2014.

    Description of Event or Problem · 1

    UPDATE 1/22/2015- MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE RECORDS INDICATE THE PATIENT'S METAL IONS LEVELS CONTINUE TO IMPROVE SIGNIFICANTLY SINCE HER REVISION TO A POLY LINER.

    Description of Event or Problem · 1

    PPF ALLEGES METAL WEAR. ADDED PATIENT'S AGE, EXPIRATION DATE OF THE IMPACTED PRODUCTS, HOSPITAL REVISION, REVISION SURGEON, LAWYER IN THE ASSOCIATED CONTACT AND LAW FIRM IN THE FACILITY NAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300139 SUMMIT POR TAPER SZ5 STD OFF SUMMIT HIP STEM : HIP FEMORAL STEM LPH DEPUY ORTHOPAEDICS INC US ER2DR1

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention