BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY X-LG STAT RT 16.5MM

    MDR report key: 2388588 · Received December 27, 2011

    Report

    Report Number
    1818910-2011-27012
    Event Type
    Injury
    Date Received
    December 27, 2011
    Date of Event
    November 28, 2011
    Report Date
    November 28, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LPH
    PMA / PMN Number
    K001778
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATE 1/25/2012 - LITIGATION PAPERS WERE RECEIVED. LITIGATION ALLEGES AFTER THE SURGERIES, THE PATIENT EXPERIENCED SEVERE PAIN AND DISCOMFORT AND INFLAMMATION IN HIS LEFT AND RIGHT THIGHS AND GROIN. HE ALSO EXPERIENCED A POPPING AND SNAPPING SENSATION IN HIS HIP-JOINTS WHEN WALKING OR MOVING TO AND FROM A SITTING POSITION. DOI: (B)(6) 2006. THE METAL-ON-METAL DEVICES HAVE BEEN ADDED TO THE COMPLAINT AS THEY ARE THE SUBJECT OF THE LITIGATION. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO RELATED MANUFACTURING DEVIATIONS OR RELATED ANOMALIES. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR STEM AND METAL INSERT PART AND LOT NUMBER COMBINATIONS; ONE PRIOR REPORT FOR THE HEAD PART AND LOT NUMBER COMBINATION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. 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.

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FOUND ADDITIONAL COMPLAINTS AGAINST THE 2222087 AND 2259361 LOT CODES. PER WI-3430, REVISION C, A REVIEW OF THE DEVICE HISTORY RECORDS FOR THESE PRODUCTS IS NO LONGER REQUIRED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: 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. 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

    PATIENT WAS REVISED TO ADDRESS STEM LOOSENING.

    Description of Event or Problem · 1

    UPDATE REC'D 10/10/2012 - PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDIAL RECORDS IT CONFIRMED LOOSENING OF THE FEMORAL STEM. THERE IS NO NEW ADDITIONAL INFOMRATION THAT WOULD AFFECT THE EXISTING MDR DECISION.

    Description of Event or Problem · 1

    IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES FRACTURE (BONE). ADDED UNKNOWN HIP IMPLANT. ADDED REVISION HOSPITAL, REVISION SURGEON AND LAWYER IN THE ASSOCIATED CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRODIGY X-LG STAT RT 16.5MM PRODIGY HIP STEM : HIP FEMORAL STEM LPH DEPUY ORTHOPAEDICS, INC. 1818910 Z2EC21000

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention