BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE FB TIB BASE SZ 4 CEM

    MDR report key: 13938478 · Received March 29, 2022

    Report

    Report Number
    1818910-2022-05724
    Event Type
    Injury
    Date Received
    March 29, 2022
    Date of Event
    February 25, 2022
    Report Date
    March 29, 2022
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    UDI-DI
    10603295042389
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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). 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. 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. 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 : A MANUFACTURING RECORD EVALUATION (MRE), WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.

    Description of Event or Problem · 0

    THIS COMPLAINT IS TO CAPTURE THE 1 X REVISION MENTIONED IN INSTRUMENT COMPLAINT (B)(4) CONFIRMED AS REVISION OF DEPUY PRODUCTS VIA RESPONSE TO "REQUEST FOR ADDITIONAL INFORMATION". INITIAL OPERATION 2018: IN THE PATIENTS NOTES FROM THE ORIGINAL OPERATION THE SURGEON COMMENTED THAT AFTER THE CUTS THE KNEE REMAINED WITH ¿GROSS TIGHTNESS¿ ON THE LATERAL SIDE. HE DOWN SIZED THE FEMUR FORM A SIZE 4 TO A SIZE 3 AND INTERNALLY ROTATED THE FEMORAL CUTS SLIGHTLY TO EASE THE TIGHTNESS. THIS WORKED TO SOME EXTENT BUT TIGHTNESS DID REMAIN. THE SURGEON DID NOT FEEL THAT THE RESIDUAL TIGHTNESS WARRANTED SOFT-TISSUE RELEASE. ACCORDING TO THE REVISION SURGEON THE PATIENT HAD EXPERIENCED POST OP PAIN AND TIGHTNESS FOR QUITE SOME TIME. THIS WAS NOT RESOLVED THROUGH PHYSIO AND EXERCISE. SO THE DECISION WAS MADE TO REVISE THE KNEE WITH THE AIM OF REDUCING PAIN AND TIGHTNESS NO BATCH NUMBERS WERE OBTAINED FROM THE EXPLANTED PROSTHESIS. THIS WAS NOT POSSIBLE DUE TO CEMENT AND TISSUE DEBRIS. (THE SECOND REVISION CASE MENTIONED IN (B)(4) DID NOT INVOLVE DEPUY SYNTHES IMPLANTS).

    Description of Event or Problem · 0

    A. PLEASE CONFIRM IF THE CEMENT WAS MANUFACTURED BY DEPUY? IF YES, PLEASE PROVIDE THE PART AND LOT NUMBERS AND QUANTITY OF THE CEMENT. - NOT KNOWN. B. WAS THERE A SURGICAL DELAY BECAUSE OF THIS EVENT? IF YES, WHAT IS THE DURATION OF THE DELAY? - NO DELAY. C. WAS THERE ANY SUGGESTION BY ANYONE INDICATING THAT THERE WAS OR MAY BE DEFICIENCY WITH THE PRODUCT(S). IF YES, PLEASE PROVIDE DETAILS. - NO SUGGESTION OF DEFICIENCY. D. WAS THE PRODUCT IMPLANTED USING DEPUY SYNTHES¿S ATTUNE FEMUR FIRST ANATOMIC ALIGNMENT SURGICAL TECHNIQUE (DSUS/JRC/0617/2179) OR THE ATTUNE ANATOMIC TIBIA BALANCED FEMUR SURGICAL TECHNIQUE (097081-180816 DSEM)? - UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749144 ATTUNE FB TIB BASE SZ 4 CEM ATTUNE IMPLANT : KNEE TIBIAL TRAY JWH DEPUY IRELAND - 9616671 1506-00-004 10603295042389

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention ATTUNE CR FB INSRT SZ 3 8MM.| ATTUNE CR FEM LT SZ 3 CEM.| ATTUNE FB TIB BASE SZ 4 CEM.| UNKNOWN BONE CEMENT.