BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE 100 ACET CUP 48MM

    MDR report key: 11649716 · Received April 12, 2021

    Report

    Report Number
    1818910-2021-07667
    Event Type
    Injury
    Date Received
    April 12, 2021
    Date of Event
    June 5, 2019
    Report Date
    March 24, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    UDI-DI
    10603295008538
    PMA / PMN Number
    P070026
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THIS DEVICE WAS MANUFACTURED ON 17-NOV-2014. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER RELATED REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT CODE/LOT NUMBER COMBINATION SINCE RELEASE FOR DISTRIBUTION. 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. DEVICE HISTORY LOT: 1) QUANTITY MANUFACTURED: 10. 2) DATE OF MANUFACTURE: 17-NOV-2014. 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: ONE NC (NON-CONFORMANCE) FOUND ASSOCIATED WITH 8023154. NC: 043435 WAS OPENED TO INTRODUCE ADDITIONAL VERIFICATION WHEN RUNNING M/C OP 2 FIRST OFF ON CMMQ0049. THIS WAS A PLANNED NC TO ALLOW START OF THE 2ND PART IN CNC AFTER GETTING THE TAPER DIAMETER MEASURED IN THE CMM ON THE 1ST OFF. THERE IS NO CORRELATION BETWEEN NC: 043435 AND THE COMPLAINT FAILURE MODE. 4) EXPIRY DATE: 31-OCT-2024. 5) IFU REFERENCE: 090200701.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    ON (B)(6) 2019, THE PATIENT UNDERWENT A LEFT HIP REVISION DUE TO MECHANICAL COMPLICATION OF INTERNAL JOINT IMPLANT. THE SURGEON NOTED A HEMATOMA, DISCOLORATION FROM METAL ABRASION, AND THE REMOVAL OF SCAR TISSUE. THE LINER WAS WORN AND DISASSOCIATED FROM THE CUP WITH MINOR CONTACT OF THE HEAD AGAINST THE METAL RING. THE HEAD AND LINER WERE EXCHANGED. THE CUP AND STEM WERE RETAINED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2015, DOR: (B)(6) 2019, LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545891 PINNACLE 100 ACET CUP 48MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS LPH DEPUY ORTHOPAEDICS INC US 1217-01-048 8023514 10603295008538

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention APEX HOLE ELIM POSITIVE STOP.| CORAIL CEM STEM STD S11.| HIP BALL BIOLOX 32 +5 12/14.| PINN MAR +4 10D 32IDX48OD.| APEX HOLE ELIM POSITIVE STOP| CORAIL CEM STEM STD S11| HIP BALL BIOLOX 32 +5 12/14| PINN MAR +4 10D 32IDX48OD