BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN SECTOR HA ACET CUP 52MM

    MDR report key: 2211757 · Received August 10, 2011

    Report

    Report Number
    1818910-2011-14472
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    July 11, 2011
    Report Date
    November 20, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    K031495
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. 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 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

    UPDATE - (B)(4) 2012 - PATIENT'S MEDICAL RECORDS WERE RECEIVED FROM LEGAL. THE REVISION OPERATIVE REPORT INDICATES THE PATIENT WAS REVISED TO ADDRESS RECURRENT DISLOCATION AND INSTABILITY. IT WAS NOTED THAT THERE WAS GROSS RETROVERSION OF THE ACETABULAR SOCKET. DOR: (B)(6) 2009. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR THE REPORTED PART AND LOT CODE COMBINATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE CORRECTIVE ACTION WAS NOT ESTABLISHED. 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

    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

    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 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).

    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

    PATIENT WAS REVISED TO ADDRESS CUP POSITION.

    Description of Event or Problem · 1

    UPDATE 11/20/2014- PFS AND MEDICAL RECORDS RECEIVED. TWO COMPLAINTS CONTAINS TWO REVISIONS. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED ON (B)(6) 2009 FOR PAIN AND ARTHROFIBROSIS. ONLY THE FEMORAL HEAD WAS REVISED. THE PATIENT WAS THEN REVISED ON (B)(6) 2011 FOR METALLOSIS, MALPOSITIONED CUP, AND FIBROSIS CAUSING IMPINGEMENT. A FEMORAL STEM IS BEING ADDED FOR THE ALLEGED HIGH METAL IONS. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION.

    Description of Event or Problem · 1

    PPF ALLEGED METALLOSIS. ADDED REVISION HOSPITAL, LAW FIRM, DOB, PRODUCT DETAILS, PRODUCT CODE (STEM), LOT NUMBER (STEM), EXPIRATION DATES (CUP, LINER, HEAD, STEM), PRODUCT CODES (CUP, LINER, HEAD, STEM), PRODUCT EXPERIENCE CODES (CUP, LINER, HEAD, STEM) AND ASSOCIATED CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINN SECTOR HA ACET CUP 52MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS LPH DEPUY ORTHOPAEDICS INC US NA ZN6DN1000

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention NA.