BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE MEDIAL DOME PAT 41MM

    MDR report key: 17063670 · Received June 5, 2023

    Report

    Report Number
    1818910-2023-11584
    Event Type
    Injury
    Date Received
    June 5, 2023
    Date of Event
    May 23, 2023
    Report Date
    June 5, 2023
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    UDI-DI
    10603295056706
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. DEVICE HISTORY LOT : THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Description of Event or Problem · 0

    CLINICAL ADVERSE EVENT RECEIVED FOR STIFFNESS AND ADHESIONS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (LEFT KNEE). TREATMENT: CLOSED REDUCTION/MANIPULATION. DEPUY PRODUCTS USED (NO REVISION COMPLETED): CATALOG ID: 151820041; LOT ID: 4032156; COMPONENT TYPE: PATELLAR; DESCRIPTION: ATTUNE MEDIAL DOME PAT 41MM. CATALOG ID: 150401109; LOT ID: 3761129; COMPONENT TYPE: FEMORAL; DESCRIPTION: ATTUNE CR FEM LT SZ 9 POR. CATALOG ID: 150621009; LOT ID: 3965860; COMPONENT TYPE: TIBIAL; DESCRIPTION: ATTUNE FB TIB BASE SZ 9 POR. CATALOG ID: 151820907; LOT ID: M0663Z; COMPONENT TYPE: INSERT; DESCRIPTION: ATTUNE LEFT MEDIAL STABILIZED INSERT SIZE 9 7MM. CATALOG ID: 3322020; LOT ID: 3958266; COMPONENT TYPE: CEMENT; DESCRIPTION: SMART SET BONE CEMENT 20G.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1189018 ATTUNE MEDIAL DOME PAT 41MM ATTUNE IMPLANT : KNEE PATELLA JWH DEPUY IRELAND - 9616671 1518-20-041 4032156 10603295056706

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention ATTUNE FB TIB BASE SZ 9 POR.| ATTUNE FEM POR CR LT SZ 9.| ATTUNE MEDIAL DOME PAT 41MM.| ATUNE CR LT MS INS SZ 9 7.| DEPUY CMW 2 20G.