BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12/14 ARTICUL 44MM M SPEC+1.5

    MDR report key: 2213438 · Received August 12, 2011

    Report

    Report Number
    1818910-2011-15394
    Event Type
    Injury
    Date Received
    August 12, 2011
    Report Date
    July 15, 2011
    Manufacturer
    DEPUY ORTHOPAEDIC INC, 1818910
    Product Code
    LPH
    PMA / PMN Number
    PK060031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR 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. 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

    NEW ETQ CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT- LITIGATION PAPERS ALLEGE: ON (B)(6) 2009, PATIENT WAS IMPLANTED WITH A DEPUY PINNACLE HIP ON HIS RIGHT SIDE. SEVERAL MONTHS AFTER THE SURGERY, PATIENT BEGAN SUFFERING FROM DISCOMFORT AND PAIN IN HIS HIPS AND GROIN AREA. IT BECAME INCREASINGLY PAINFUL FOR HIM TO WALK AND MOVE HIS LEGS. HE INTENDS TO UNDERGO REVISION SURGERY IF INDICATED BY HIS DOCTOR. UPDATE REC'D 11/14/2012¿ PFS AND MEDICAL RECORDS RECEIVED. PART/LOT INFO RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON : 6/9/2014. DOI: (B)(6) 2009 - DOR: N/I (RIGHT SIDE). 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. 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

    (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. 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.

    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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: ON (B)(6) 2009, PT WAS IMPLANTED WITH A DEPUY PINNACLE HIP ON HIS RIGHT SIDE. SEVERAL MONTHS AFTER THE SURGERY, PT BEGAN SUFFERING FROM DISCOMFORT AND PAIN IN HIS HIPS AND GROIN AREA. IT BECAME INCREASINGLY PAINFUL FOR HIM TO WALK AND MOVE HIS LEGS. HE INTENDS TO UNDERGO REVISION SURGERY IF INDICATED BY HIS DOCTOR.

    Description of Event or Problem · 1

    UPDATE REC'D 11/14/2012 - PFS AND MEDICAL RECORDS RECEIVED. PART/LOT INFO RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION.

    Description of Event or Problem · 1

    THE LOT NUMBER OF THE HEAD THAT WAS PROVIDED IS NOT VALID IN UNITY AND IN AS400. THE PATIENT UNDERWENT BILATERAL TOTAL ARTHROPLASTY, HOWEVER ONLY THE RIGHT HIP HAS AN ALLEGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12/14 ARTICUL 44MM M SPEC+1.5 HIP FEM. HEAD LPH DEPUY ORTHOPAEDIC INC, 1818910 NA 2760423

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention