BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE SECTOR II CUP 50MM

    MDR report key: 2141302 · Received June 22, 2011

    Report

    Report Number
    1818910-2011-11040
    Event Type
    Injury
    Date Received
    June 22, 2011
    Report Date
    November 8, 2012
    Manufacturer
    DEPUY ORTHOPAEDIC INC, 1818910
    Product Code
    LPH
    PMA / PMN Number
    PK000306
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE INVESTIGATION IS ONGOING. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    LITIGATION PAPERS ALLEGE ON (B)(6) 2008, PATIENT WAS FORCED TO UNDERGO REVISION OF THE RIGHT TOTAL HIP REPLACEMENT DUE TO HIP REPLACEMENT FAILURE, WITH LOOSENED ACETABULAR COMPONENTS AND NO BONE GROWTH ON THE ACETABULUM. DOI: (B)(6) 2006 - DOR: (B)(6) 2008 (RIGHT SIDE). 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

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (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.

    Description of Event or Problem · 1

    UPDATE 11/8/12- PFS RECEIVED. PFS REVIEWED FOR MDR REPORTABILITY. THE PFS REPORTED PAIN IN HIP AND GROIN, LIMITED RANGE OF MOTION, AND THAT PATIENT CANNOT BEND OR SQUAT WITHOUT ASSISTANCE. THE PAIN ALLEGED CAN BE ATTRIBUTED TO THE LOOSE CUP AND SCREWS. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING INVESTIGATION. THE COMPLAINT WAS UPDATED ON: JAN 5, 2016.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE ON (B)(6), 2008, PT WAS FORCED TO UNDERGO REVISION OF THE RIGHT TOTAL HIP REPLACEMENT DUE TO HIP REPLACEMENT FAILURE, WITH LOOSENED ACETABULAR COMPONENTS AND NO BONE GROWTH ON THE ACETABULUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE SECTOR II CUP 50MM ACETABULAR SHELL LPH DEPUY ORTHOPAEDIC INC, 1818910 NA ZY9E21000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention