BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE PS FEM RT SZ 9 CEM

    MDR report key: 10104191 · Received June 1, 2020

    Report

    Report Number
    1818910-2020-12897
    Event Type
    Injury
    Date Received
    June 1, 2020
    Date of Event
    November 12, 2018
    Report Date
    May 20, 2020
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    UDI-DI
    10603295041801
    PMA / PMN Number
    K111433
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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 : A REVIEW OF THE DEVICE MANUFACTURING RECORDS (DHR) WAS PERFORMED, PRODUCT CODE 150410209, WORK ORDER (B)(4) WAS MANUFACTURED ON 24 JUN 2015. (B)(4) PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. SCRAP: THERE WAS NO SCRAP ASSOCIATED WITH THIS LOT. REPROCESSING: THERE WAS NO MATERIAL REPROCESSING REPORTS (MRR) ASSOCIATED WITH THIS LOT. NON-CONFORMANCE: 2 NON-CONFORMANCES ASSOCIATED WITH THIS LOT: NR-0100007 IS RELATED TO INCORRECT DRAWING REVISION ON INSPECTION SHEET DID NOT MATCH REVISION ON LOT TRAVELLER AFFECTING ATTUNE PS FEM LT PRODUCT. THERE IS NO CORRELATION BETWEEN THIS NON-CONFORMANCE AND THE FAILURE MODE OF THE COMPLAINT. NR-0142098 IS RELATED TO CTQ 27 NOT REFERENCED IN GAUGE R&R BUT REFERENCED IN CTQ LIST FOR ATTUNE PS PRIMARY AND ATTUNE PS CLS. THERE IS NO CORRELATION BETWEEN THIS NON-CONFORMANCE AND THE FAILURE MODE OF THE COMPLAINT.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY SYNTHESE 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: ADDED: A1, A2 (DATE OF BIRTH), B5, B7, D4 (EXPIRATION DATE) AND G2. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. CORRECTED: E1, H4 AND H6 (DEVICE CODE).

    Description of Event or Problem · 0

    MEDICAL RECORDS RECEIVED AND REVIEWED: PATIENT RECEIVED BILATERAL ATTUNE TOTAL KNEES DUE TO DEGENERATIVE JOINT DISEASE. THE RIGHT PATELLA WAS RESURFACED AND DEPUY CEMENT X 3 WAS UTILIZED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. PATIENT RECEIVED A RIGHT KNEE REVISION TO ADDRESS PAIN, TIBIAL TRAY MIGRATION, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON NOTED THE REVISED FEMORAL COMPONENT WAS SLIGHTLY OVERSIZED. THE TIBIAL TRAY, TIBIAL INSERT, AND FEMORAL COMPONENT WERE REVISED. THE PATELLAR COMPONENT WAS RETAINED. THE PATIENT WAS REVISED WITH COMPETITOR PRODUCTS AND CEMENT. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORTER OCCUPATION: LAWYER. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    ATTUNE KNEE CLAIM RECORD RECEIVED. CLAIM RECORD ALLEGES INJURIES, PAIN, ANGUISH, DISFIGUREMENT AND PHYSICAL IMPAIRMENT. DOI: (B)(6) 2016. DOR: (B)(6) 2018. RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567789 ATTUNE PS FEM RT SZ 9 CEM ATTUNE IMPLANT : KNEE FEMORAL JWH DEPUY IRELAND - 9616671 1504-10-209 8139575 10603295041801

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention ATTUNE MEDIAL DOME PAT 41MM| ATTUNE PS FEM RT SZ 9 CEM| ATTUNE PS RP INSRT SZ9 5MM| ATTUNE RP TIB BASE SZ 9 CEM| DEPUY CMW 2 20G| DEPUY CMW 2 20G| DEPUY CMW 2 20G| ATTUNE MEDIAL DOME PAT 41MM| ATTUNE PS FEM RT SZ 9 CEM| ATTUNE PS RP INSRT SZ9 5MM| ATTUNE RP TIB BASE SZ 9 CEM| DEPUY CMW 2 20G| DEPUY CMW 2 20G| DEPUY CMW 2 20G