BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT POR TAPER SZ5 HI OFF

    MDR report key: 3933390 · Received July 14, 2014

    Report

    Report Number
    1818910-2014-23345
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    March 1, 2012
    Report Date
    June 27, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    PK001991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE 2062470 LOT CODE DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE REMAINING PRODUCT AND LOT COMBINATION. 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.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER WPC (B)(4). REASON FOR ORIGINAL COMPLAINT.- LITIGATION ALLEGES THAT PATIENT EXPERIENCED DEBILITATING PAIN, DISCOMFORT, DISFIGURATION, AND SORENESS IN THE AREA OF THE HIP IMPLANT, THEREBY NEGATIVELY AFFECTING PATIENT'S ABILITY TO PERFORM ACTIVITIES OF DAILY LIVING. ADDITIONALLY, IT IS ALLEGED THAT PATIENT HAS METAL IONS AND PARTICLES IN THEIR BLOOD, TISSUE, AND BONE SURROUNDING THE IMPLANT. UPDATE: (B)(4) 2012 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. UPDATE REC'VD (B)(4) 2014- PATIENT WAS REVISED TO ADDRESS ELEVATED ION LEVELS. THIS COMPLAINT WAS UPDATED (B)(4) 2014. UPDATE REC'D (B)(4) 2014- PFS AND MEDICAL RECORDS RECEIVED. PART/LOT WAS PROVIDED. AFTER THE REVIEW OF THE MEDICAL RECORDS IT DISCOVERED THE PATIENT HAD A REVISION ON (B)(6) 2014. THE REVISION OPERATIVE NOTE INDICATED THERE WAS CORROSION ON THE TRUNNION OF THE STEM. THE STEM IS BEING ADDED TO THE COMPLAINT. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON:

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409459 SUMMIT POR TAPER SZ5 HI OFF HIP FEMORAL STEM/SLEEVE LPH DEPUY ORTHOPAEDICS INC US ZX7GE1000

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR