BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFC*SIGMA DI AUG16MMCO,SZ3LEFT

    MDR report key: 13099722 · Received December 28, 2021

    Report

    Report Number
    1818910-2021-28895
    Event Type
    Malfunction
    Date Received
    December 28, 2021
    Date of Event
    December 15, 2021
    Report Date
    December 28, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 (COUNTRY CODE). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. CORRECTED: H5, H8.

    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: 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 - EXAMINATION OF THE RETURNED SIGMA AUGMENT CONFIRMED INNER FOAM PACKAGING RESIDUE/DEBRIS WAS FOUND TRANSFERRED TO THE SURFACE OF THE DEVICE. THE DEBRIS WAS FOUND IN RAYNHAM DURING REPACKING/RESTERILIZATION OF EXPIRED STERILE PRODUCT RETURNED FROM THE FIELD. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. 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). WHERE THE PRODUCT AND LOT CODE WAS PROVIDED, A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED. H10 ADDITIONAL NARRATIVE: ADDED: D9 CORRECTED: H3.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (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 · 0

    A. HOSPITAL NAME/ACCOUNT NUMBER: NA. B. PRODUCT NUMBER: PFC SIGMA AUGMENT 960871. C. LOT NUMBER: PFC SIGMA AUGMENT (B)(6). D. PLEASE CONFIRM IF THE REPORTED IMPLANT IS AVAILABLE FOR RETURN. YES, AVAILABLE FOR RETURN.

    Description of Event or Problem · 0

    MULTIPLE PARTS DISPLAYED A VISUAL COSMETIC DEFECT ON THE TOP SURFACE. FOAM PARTICLES WERE TRANSFERRED FROM THE PACKAGING ONTO THE COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1995884 PFC*SIGMA DI AUG16MMCO,SZ3LEFT SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY JWH DEPUY ORTHOPAEDICS INC US EG3JJ4
    1995886 PFC*SIGMA DI AUG16MMCO,SZ3LEFT SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY JWH DEPUY ORTHOPAEDICS INC US EG3JJ4

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown PFC*SIGMA DI AUG16MMCO,SZ3LEFT.| PFC*SIGMA DI AUG16MMCO,SZ3LEFT.| PFC*SIGMA DI AUG16MMCO,SZ3LEFT.| PFC*SIGMA DI AUG16MMCO,SZ3LEFT.| PFC*SIGMA DI AUG16MMCO,SZ3LEFT.| PFC*SIGMA DI AUG16MMCO,SZ3LEFT.| PFC*SIGMA DI AUG16MMCO,SZ3LEFT.| PFC*SIGMA DI AUG16MMCO,SZ3LEFT.| PFC*SIGMA DI AUG16MMCO,SZ3LEFT.| PFC*SIGMA DI AUG16MMCO,SZ3LEFT.| PFC*SIGMA DI AUG16MMCO,SZ3LEFT.| PFC*SIGMA DI AUG16MMCO,SZ3LEFT.