BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA CRVD INSERT SZ4 8MM

    MDR report key: 6121786 · Received November 22, 2016

    Report

    Report Number
    1818910-2016-32022
    Event Type
    Injury
    Date Received
    November 22, 2016
    Date of Event
    November 18, 2016
    Report Date
    November 18, 2016
    Manufacturer
    DEPUY-RAYNHAM 1219655
    Product Code
    JWH
    PMA / PMN Number
    K943462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. ANOTHER REPORT IS FOUND AGAINST THE REPORTED PFC*SIGMA C/R NPOR FEM LT SZ 4 (PRODUCT CODE 960004, LOT NUMBER 277968) AND PFC*SIGMA/OV/DOME PAT 3PEG,38 (PRODUCT CODE 960102, LOT NUMBER 278428). IT IS RECOGNIZED HOWEVER THAT IT INVOLVES THIS SAME PATIENT AND SAME INDIVIDUAL DEVICE. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE REMAINING PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. 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 THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THE INVESTIGATION WILL BE REOPENED.

    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. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. (B)(4).

    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.

    Description of Event or Problem · 1

    UPDATE 12/14/2016: MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED OSTEOLYSIS, POLY WEAR, FEMORAL COMPONENT LOOSENING (CEMENT-IMPLANT INTERFACE), TIBIAL COMPONENT LOOSENING (CEMENT-IMPLANT INTERFACE), PATELLA LOOSENING (UNKNOWN INTERFACE), AND PATELLA BAJA. THE CEMENT MANUFACTURER IS STILL UNKNOWN. THE TIBIAL TRAY IS BEING ADDED TO THE COMPLAINT.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN, OSTEOLYSIS AND FEMORAL LOOSENING AT THE CEMENT/IMPLANT INTERFACE. THE CEMENT MANUFACTURER IS UNKNOWN. CLINICAL DER WAS ALSO RECEIVED AND STATES FEMORAL LOOSENING AND OSTEOLYSIS.

    Description of Event or Problem · 1

    UPDATE: 11/18/2016: MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770537 PFC SIGMA CRVD INSERT SZ4 8MM KNEE TIBIAL BEARING/INSERT JWH DEPUY-RAYNHAM 1219655 70783A

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention