BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIG RPF INS SZ 3 15MM

    MDR report key: 8743967 · Received June 28, 2019

    Report

    Report Number
    1818910-2019-97066
    Event Type
    Injury
    Date Received
    June 28, 2019
    Date of Event
    June 10, 2019
    Report Date
    June 9, 2019
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    NJL
    UDI-DI
    10603295230397
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: NO DEVICE WAS RECEIVED. ROOT CAUSE UNDETERMINED. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: NULL. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW: NULL. 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

    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. (B)(4).

    Description of Event or Problem · 1

    THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2011 FOR THE PATIENT HAS PARKINSON'S DISEASE. IT WAS REPORTED THAT DISLOCATION OCCURRED AFTER 2 WEEKS FROM THE PRIMARY SURGERY. AFTER THAT, DISLOCATION HAD OCCURRED 1-2 TIMES A MONTH AND FREQUENT DISLOCATION HAD RECURRED RECENTLY. THE FEMUR WAS DISLOCATED TO THE ANTERIOR WHEN THE PATIENT STOOD UP, IT WAS CONFIRMED THAT THERE WAS A SUSPECTED THE TIBIAL INSERT SPINOUT AT X-RAY. THUS, THE REVISION SURGERY WAS PERFORMED BY REPLACING THE TIBIAL INSERT (P/N: 951032) TO ONE SIZE BIGGER 17.5MM TIBIAL INSERT ON (B)(6) 2019. THE SURGERY WAS COMPLETED WITHOUT A SURGICAL DELAY. IT WAS CONFIRMED THAT WEAR OF THE TIBIAL INSERT ANTERIOR LIP AND THE TIBIAL INSERT POST. POSSIBLE CAUSE: INSUFFICIENT REMOVAL OF TISSUE SUCH AS OUTER MENISCUS, INSUFFICIENT GAP MANAGEMENT AT THE PRIMARY SURGERY (BECAUSE THE EXTENSION GAP WAS LOOSE THAN FLEXION GAP). NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540139 PFC SIG RPF INS SZ 3 15MM PFC SIGMA RP-F : KNEE TIBIAL INSERT NJL DEPUY INTERNATIONAL LTD. 8010379 CN7HT4000 10603295230397

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention