BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE SECTOR II CUP 52MM

    MDR report key: 3162562 · Received June 11, 2013

    Report

    Report Number
    1818910-2013-18612
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 23, 2013
    Report Date
    February 26, 2015
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK000306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    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

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. NO INFORMATION PERTAINING TO THE SALES REP IS AVAILABLE AND THE HOSPITAL WILL NOT PROVIDE INFORMATION. THEREFORE, REQUESTS FOR ADDITIONAL INFORMATION COULD NOT BE COMPLETED AND NO ADDITIONAL INFORMATION OBTAINED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.ADDITIONAL INFORMATION: 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. NO INFORMATION PERTAINING TO THE SALES REP IS AVAILABLE AND THE HOSPITAL WILL NOT PROVIDE INFORMATION. THEREFORE, REQUESTS FOR ADDITIONAL INFORMATION COULD NOT BE COMPLETED AND NO ADDITIONAL INFORMATION OBTAINED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. 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 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). 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

    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. 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

    (B)(4) RECEIVED FROM HOSPITAL STATES THAT PATIENT WAS REVISED TO ADDRESS PAIN DUE TO LOOSENING OF THE CUP. INTRAOPERATIVELY, THE PATIENT WAS ALSO FOUND TO HAVE SIGNIFICANT METALLOSIS AND ABDUCTOR DAMAGE FROM THE METALLOSIS. THE CUP WAS GROSSLY LOOSE.

    Description of Event or Problem · 1

    UPDATE 11/30/2015- PFS AND MEDICAL RECORDS RECEIVED. PFS AND MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. PFS REPORTED DISLOCATION, DIFFICULTY WALKING, PSEUDOTUMOR, LOOSENING, SLEEP DEPRIVATION AND WEAKNESS RELATED TO MUSCLE DETERIORATION. THERE WAS NO PSUEDOTUMOR REPORTED IN THE REVISION SURGICAL REPORT OR ANY TESTS RESULTS CONFIRMING PSEUDOTUMOR. THERE WERE NO LAB RESULTS FOR THE ALLEGED HIGH METAL IONS. THE DISLOCATION APPLIES TO (B)(4). THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING INVESTIGATION. THE COMPLAINT WAS UPDATED ON: DEC 16, 2015.

    Description of Event or Problem · 1

    PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE CONFIRMED LOOSE CUP AND METALLOSIS. NO LABS WERE PROVIDED FOR THE ALLEGED HIGH METAL IONS. PART/LOT IS BEING ADDED FOR THE UNKNOWN STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262721 PINNACLE SECTOR II CUP 52MM ACETABULAR CUP LPH 1818910 DEPUY ORTHOPAEDICS, INC. Z5CC51000

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention