BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN MAR +4 10D 28IDX46OD

    MDR report key: 7832157 · Received August 30, 2018

    Report

    Report Number
    1818910-2018-68097
    Event Type
    Injury
    Date Received
    August 30, 2018
    Date of Event
    August 4, 2018
    Report Date
    August 4, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LPH
    UDI-DI
    10603295013440
    PMA / PMN Number
    K033273
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. CONCOMITANT MED PRODUCTS: PINN MAR +4 10D 28IDX46OD; DELTA CER HEAD 12/14 28MM +1.5; UNKNOWN HIP FEMORAL STEM; UNKNOWN HIP ACETABULAR CUP.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # : (B)(4). INVESTIGATION SUMMARY: EXAMINATION OF THE ACETABULAR LINER DOES FIND EVIDENCE TO SUPPORT THE REPORTED DISASSOCIATION EVENT. PRODUCT ERROR / CONTRIBUTION TO THE EVENT IS NOT IDENTIFIED. 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

    THE PATIENT HAD PTQ 4 YEARS AGO AND HER INSERT WAS DISPLACED FROM THE ACETABULUM. I FORWARD PHOTOS OF THE PRIMARY EXAMINATION, THE CASE OF THE EVOLUTION OF THE CASE AND ALSO THE BOX WITH THE IMPLANTS FOR ANALYSIS. THE PATIENT DID NOT NEED TO BE HOSPITALIZED FOR THIS REASON, NOR DID SHE HAVE ANY COMPLICATIONS DURING THE SURGERY. PRODUCT INFORMATION: REF. (B)(4), LOT 132163 - ACETABULAR LINER 28MM, REF. (B)(4), LOT 3512554 - CERAMIC FEMORAL HEAD 28 MM 12/14. THE REVIEW WAS PERFORMED ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675254 PINN MAR +4 10D 28IDX46OD PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS LPH DEPUY ORTHOPAEDICS, INC. 1818910 132163 10603295013440

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention