BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE PS FB INSRT SZ 8 8MM

    MDR report key: 11750269 · Received April 29, 2021

    Report

    Report Number
    1818910-2021-09246
    Event Type
    Injury
    Date Received
    April 29, 2021
    Report Date
    April 14, 2021
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    OIY
    UDI-DI
    10603295050377
    PMA / PMN Number
    K111433
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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: B5 AND D10. 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. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY 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). WHERE THE PRODUCT AND LOT CODE WAS PROVIDED, A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Description of Event or Problem · 0

    A. WAS SURGERY TIME EXTENDED? IF YES, WHAT WAS THE DURATION OF THE DELAY? ANSWER: NO, THE OPERATION TIME HAS NOT BEEN EXTENDED. B. PLEASE CONFIRM IF THE CEMENT WAS MANUFACTURED BY DEPUY? IF YES, PLEASE PROVIDE THE QUANTITY, PART AND LOT NUMBERS OF THE CEMENT. ANSWER: SMARTSET GMV ENDURANCE, 40 GR: REF: (B)(4); LOT: 9102841. IMAGE ATTACHED. RADIOGRAPHS/X-RAY FILMS PLEASE PROVIDE ALL X-RAYS RELEVANT TO THE REPORTED EVENT FOR EXAMPLE - PRE-OPERATIVE, POST PRIMARY, PRE-REVISION AND INTERVENING TIME POINTS. - X RAY IMAGES ATTACHED. PATIENT DEMOGRAPHICS THE FOLLOWING ARE THE TYPES OF PATIENT DEMOGRAPHICS WE REQUIRE: RELEVANT COMORBIDITIES. - N/A. PATIENT RECORDS CAN¿T BE ACCESSED FOR PRIVACY REASONS. THE VERBALLY OBTAINED INFORMATION IS THAT THE PATIENT DOES NOT HAVE PRONOUNCED COMORBIDITIES THAT WOULD AFFECT POSTOPERATIVE RECOVERY.

    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

    (B)(6) 2020 REVISION KNEE SURGERY. POST-REVISION CURRENT STATE: LOW GRADE INFECTION STATUS - NEGATIVE (MICROBIOLOGICAL TRIALS WITH SEVERAL TISSUE SAMPLES). PATIENT STILL FEELS DISCOMFORT IN MOTION AND PERIODIC ANTERIOR KNEE PAIN. CONCILIAR DECISION: REHABILITATION WITH PATIENT MONITORING; REINTERVENTION BY ARTHROSCOPIC METHOD: LATERAL RETINACULAR RELEASE AND REDUCTION OF THE PATELLAR RIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640935 ATTUNE PS FB INSRT SZ 8 8MM ATTUNE IMPLANT : KNEE TIBIAL INSERT OIY DEPUY IRELAND - 9616671 1516-40-808 HC8950 10603295050377

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ATTUNE FB TIB BASE SZ 7 CEM| ATTUNE PS FEM LT SZ 8 CEM| SMARTSETGMV ENDURANCE GENT 40G