BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN CAN BONE SCREW 6.5MMX20MM

    MDR report key: 4092875 · Received September 16, 2014

    Report

    Report Number
    1818910-2014-28185
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    December 5, 2011
    Report Date
    March 26, 2013
    Manufacturer
    DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS ¿ REG.
    Product Code
    NDJ
    PMA / PMN Number
    PK983014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A COMPLAINT DATABASE SEARCH FINDS OTHER REPORTED INCIDENTS AGAINST PRODUCT CODES 121720500 AND 121730058, LOTS 442046 AND E14K31. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THESE PRODUCT/LOT COMBINATIONS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. A COMPLAINT DATABASE SEARCH ON THE REMAINING PRODUCT CODE/LOT NUMBERS FINDS NO ADDITIONAL REPORTS. 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.

    Description of Event or Problem · 1

    PPD AND MEDICAL RECORDS RECEIVED. PART/LOT INFORMATION RECEIVED. POST-OPERATIVE PROGRESS NOTE INDICATED THE PATIENT WAS REVISED ON (B)(6) 2011 FOR A FAILED RIGHT HIP. THE REASON FOR REVISION IS UNKNOWN AT THIS TIME, BUT SINCE A PPD WAS RECEIVED AND THIS COMPLAINT IS LEGAL AS IMPLANTS REVISED ARE BEING REPORTED. THE STICKER SHEET ONLY INCLUDES 4 ACETABULAR SCREWS, BUT THE PRIMARY OPERATIVE NOTE STATES 5 SCREWS WERE IMPLANTED SO 1 UNKNOWN SCREW IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571093 PINN CAN BONE SCREW 6.5MMX20MM HIP OTHER IMPLANT-SCREW NDJ DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS ¿ REG. 437445

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention