BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE MEDIAL DOME PAT 38MM

    MDR report key: 10656945 · Received October 9, 2020

    Report

    Report Number
    1818910-2020-21874
    Event Type
    Injury
    Date Received
    October 9, 2020
    Date of Event
    September 28, 2020
    Report Date
    September 28, 2020
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    UDI-DI
    10603295056690
    PMA / PMN Number
    K103756
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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: E1 (HOSPITAL NAME AND ADDRESS), E3, E4, B5 AND D11 CORRECTED: E1 (REPORTER NAME), G1 AND G2. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT 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. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER RELATED REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT CODE/LOT NUMBER COMBINATION 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. UPDATE 08-NOV-2021. UPDATE 30 OCT 2021 RECEIVED DID NOT HAVE ANY ADDITIONAL DETAILS TO BE ADDED IN INVESTIGATION. 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY = NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER RELATED REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT CODE/LOT NUMBER COMBINATION 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.

    Description of Event or Problem · 0

    1. WAS THE CEMENT PRODUCT MANUFACTURED BY DEPUY? NO. 2. PLEASE VERIFY IF LOT CODE WY1930 (ATTUNE PS FB INSRT SZ 8 5MM) IS CORRECT AS THIS IS NOT RECOGNIZED BY THE SYSTEM. NOT AVAILABLE TO THE REP AT THIS TIME. 3. IT WAS INDICATED THAT THE PATIENT HAS HAD MULTIPLE POLY SWAPS WITH I&D. DID THE PREVIOUS REVISION(S) INVOLVE REMOVAL OF DEPUY PRODUCTS? THESE ARE ALL IDENTIFIED IN PRIOR MDRS ASSOCIATED WITH THE PT. 4. A PRODUCT COMPLAINT WAS REPORTED ON (B)(6) 2020 (DUE TO INFECTION WHEREIN I&D AND POLY EXCHANGE WERE DONE) WHICH IS (B)(4). IS THIS ONE OF THE REVISION SURGERIES THAT WERE REPORTED INVOLVING THIS PATIENT? YES. 5. WAS THE PRODUCT IMPLANTED USING DEPUY SYNTHES? ATTUNE FEMUR FIRST ANATOMIC ALIGNMENT SURGICAL TECHNIQUE (DSUS/JRC/0617/2179) OR THE ATTUNE ANATOMIC TIBIA BALANCED FEMUR SURGICAL TECHNIQUE (097081-180816 DSEM)? FEMUR FIRST.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    THE PATIENT WAS REVISED TO ADDRESS INFECTION AND ANTIBIOTIC SPACER WAS IMPLANTED. THE PATIENT HAS HAD MULTIPLE POLY SWAPS WITH I&D. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1121745 ATTUNE MEDIAL DOME PAT 38MM ATTUNE IMPLANT : KNEE PATELLA JWH DEPUY IRELAND - 9616671 1518-20-038 9320352 10603295056690

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention ATTUNE FB TIB BASE SZ 8 CEM| ATTUNE MEDIAL DOME PAT 38MM| ATTUNE PS FB INSRT SZ 8 5MM| ATTUNE PS FEM LT SZ 8 CEM| COMPETITOR BONE CEMENT| ATTUNE FB TIB BASE SZ 8 CEM| ATTUNE MEDIAL DOME PAT 38MM| ATTUNE PS FB INSRT SZ 8 5MM| ATTUNE PS FEM LT SZ 8 CEM