BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK KNEE FEMORAL SIGMA

    MDR report key: 15409184 · Received September 13, 2022

    Report

    Report Number
    1818910-2022-17477
    Event Type
    Injury
    Date Received
    September 13, 2022
    Date of Event
    January 1, 2020
    Report Date
    September 8, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THE DEVICE CATALOG NUMBER IS UNKNOWN; THEREFORE, UDI IS UNAVAILABLE. DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, 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 MEDWATCH, A FOLLOW-UP MEDWATCH 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. THIS COMPLAINT WAS OPENED TO DOCUMENT COMPLAINTS DERIVED THROUGH A JOURNAL ARTICLE REVIEW. FOLLOW-UPS WERE DONE TO TRY AND OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR OF THE JOURNAL ARTICLE. NO FURTHER INFORMATION WAS RECEIVED. 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

    ARTICLE ENTITLED ¿PERI-PROSTHETIC TRANS-PATELLAR FRACTURES AFTER TOTAL KNEE ARTHROPLASTY: A CASE SERIES AND REVIEW OF LITERATURE¿ WRITTEN BY GAURAV GOVIL, LAVINDRA TOMAR, AND PAWAN DHAWAN PUBLISHED IN ARTHROPLASTY IN 2020 WAS REVIEWED. THIS REPORT INTRODUCED THE TREATMENTS OF PERI-PROSTHETIC PATELLA FRACTURE (PPPFS), WITH A REVIEW OF THE LITERATURE CONDUCTED. 6 PATIENTS SUSTAINED PPPFS AFTER TKA. THE PROSTHESES INCLUDED CEMENTED POSTERIOR STABILIZED PRESS-FIT CONDYLAR IMPLANTS (SIGMA, DEPUY ORTHOPAEDICS INC., IN, USA) (N 4) AND IMPLANTS WITH A TIBIAL STEM EXTENDER AND A HIGH-FLEXION ROTATING PLATFORM (SIGMA, DEPUY ORTHOPAEDICS INC., IN, USA) (N 2). THERE WERE TWO RESURFACED PATELLAE AND FOUR NON-RESURFACED PATELLAE. ADVERSE EVENTS: CASE #1 ¿ AGE 68 FEMALE WITH LEFT TKA. PATELLA FRACTURE CAUSED BY A FALL. TREATMENT INCLUDED ORIF WITH CERCLAGE AND SUTURING. 1-YEAR POST-OP ¿ OUTCOMES WAS GOOD. X-RAYS INCLUDED WITHIN FIGURE 1 INDICATED EXTENSOR MECHANISM RUPTURE. CASE #2 ¿ AGE 65 FEMALE WITH LEFT TKA. PATELLA WASN¿T RESURFACED, BUT ALSO SUSTAINED AN EXTENSOR MECHANISM RUPTURE (FIGURE 2). 1-YEAR POST-OP ¿ OUTCOMES WAS FAIR. CASE #5 ¿ AGE 48 MALE WITH LEFT TKA. PATELLA FRACTURE NOT RELATED TO TRAUMA. TREATMENT INCLUDED CAST. 1-YEAR POST-OP ¿ OUTCOMES WAS EXCELLENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1952284 UNK KNEE FEMORAL SIGMA FEMORAL  JWH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention