BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE CR FEM LT SZ 5 CEM

    MDR report key: 4504266 · Received February 10, 2015

    Report

    Report Number
    1818910-2015-13150
    Event Type
    Injury
    Date Received
    February 10, 2015
    Date of Event
    November 13, 2014
    Report Date
    January 21, 2015
    Manufacturer
    1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC
    Product Code
    NJL
    PMA / PMN Number
    PP830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. PER CUSTOMER REQUEST, DHR REVIEWS WERE CONDUCTED ON THE ATTUNE CR FEM LET SZ 5 CEM, ATTUNE CR FB INSERT SZ 5 8MM AND THE ATTUNE MEDIAL DOME PAT 32MM. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES ON THE PROVIDED PRODUCT AND LOT COMBINATIONS. A DHR ANALYSIS WAS NOT REQUESTED FOR THE NONCONTRIBUTING PRODUCT FOR THIS EVENT. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED 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

    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. (B)(4).

    Description of Event or Problem · 1

    REC'D (B)(4) 2015, LEFT KNEE; ADE/LEFT PATELLA FRACTURE. FOR STUDY KNEE: YES. NOT SERIOUS, MODERATE SEVERITY, POSSIBLY DEVICE RELATED AND NOT PROCEDURE RELATED. TREATMENT: DIAGNOSTIC INTERVENTION AND OBSERVATION. NOT RECOVERED/NOT RESOLVED. SADE/OPEN REDUCTION INTERNAL FIXATION FOR FRACTURED L PATELLA USING K-WIRE. PATELLA BUTTON STABLE, FIXED AND IN PLACE. FOR STUDY KNEE: YES. TREATMENT: MEDICAL INTERVENTION/MODIFICATION, DIAGNOSTIC INTERVENTION, SURGICAL TREATMENT OF STUDY KNEE: ORIF L PATELLA WIT K-WIRE. PATELLA BUTTON STABLE SO LEFT AS WAS. SADE/FAILED FIXATION OF PREVIOUS ORIF L PATELLA O (B)(6) 2014. OPEN PROCEDURE REPAIR OF PATELLA TENDON (BURNELL REPAIR). K-WIRE DYSFUNCTIONAL BUT LEFT WITH VIEW TO REMOVE AT 3 MONTHS POST REPAIR. FOR STUDY KNEE: YES. TREATMENT MEDICAL INTERVENTION/MODIFICATION, DIAGNOSTIC INTERVENTION, SURGICAL TREATMENT OF STUDY KNEE: BURNELL REPAIR. RECOVERING/ RESOLVING. SADE/L KNEE WOUND INFECTION WASHOUT. POST FAILURE OF ORIF FOR FRACTURE L PATELLA. REMOVAL OF K-WIRE, LOOSE PATELLA PIECES, PATELLA BUTTON, ETHIBOND AND VICRYL. FOR STUDY KNEE: YES. TREATMENT: MEDICAL INTERVENTION/MODIFICATION, DIAGNOSTIC INTERVENTION, CULTURE TAKEN, SURGICAL TREATMENTS FOR STUDY KNEE: L KNEE WOUND INFECTION WASHOUT POST FAILURE OF ORIF FOR FRACTURE L PATELLA. REMOVAL OF K-WIRE, LOOSE PATELLA PIECES, PATELLA BUTTON, ETHIBOND AND VICRYL WIT WASHOUT IV ANTIBIOTICS. NOT RECOVERED/NOT RESOLVED. SERIOUS, SEVERE, DEFINITELY DEVICE RELATED AND POSSIBLY PROCEDURE RELATED. DIAGNOSIS FOR PRIMARY KNEE SURGERY: OSTEOARTHRITIS. COMORBIDITIES: BACK PAIN, DEPRESSION AND OSTEOPOROSIS. (B)(6) 2015 - EMAIL RECEIVED FROM (B)(6). UPDATE TO COMPLAINT DESCRIPTION AS FOLLOWS: PATIENT TRIPPED AND FELL ONTO TRIAL KNEE RESULTING IN TRAUMA AND A LEFT PATELLA FRACTURE (SAME KNEE AS WAS REPLACED). THIS WAS NOT PICKED UP BY PATIENT AT THE TIME BUT WAS NOTED ON XRAY AT PATIENTS STANDARD 6-MONTH POST-OPERATIVE FOLLOW UP APPOINTMENT. PETER LEWIS WAS CONSULTED AND IT WAS DECIDED THE BEST COURSE OF ACTION WAS CONSERVATIVE NON SURGICAL MANAGEMENT OF THE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97686 ATTUNE CR FEM LT SZ 5 CEM KNEE FEMORAL COMPONENT NJL 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC 322317

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention