BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP COMPONENTS

    MDR report key: 21270372 · Received January 29, 2025

    Report

    Report Number
    1038671-2025-00553
    Event Type
    Injury
    Date Received
    January 29, 2025
    Date of Event
    January 14, 2025
    Report Date
    April 2, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B1, H3. THE FOLLOWING SECTIONS WERE CORRECTED: B3: EVENT DATE DOES NOT APPLY.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 188-01-04 - WEDGE PLASMA X/O SZ 4 4178597. 180-65-30 - ALTEON 6.5MM SCREW, 30MM 4667809. 101-05-20 - 3.2MM DRILL BIT 20MM 1PK 4782114. 186-01-48 - INTEGRIP CC, CLUSTER 48MM, G1 4834922. 142-32-93 - COCR FEM HEAD 32MM -3.5 OFFSET 12/14 4975337. 140-32-51 - NV EHXL NTRL LNR G1 32MM 6073090.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: D1, E1, E2, G2 AND H6 - (COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSION). THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/ TECHNIQUE. A REVIEW OF MANUFACTURING DATA WAS UNABLE TO BE PERFORMED AS THE LOT INFORMATION OF THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEMALE PATIENT, INITIAL RIGHT HIP IMPLANTED IN (B)(6) 2017, WHO WAS REVISED IN (B)(6) 2024, STATED SHE HAD HIP REPLACEMENT SURGERY, WHICH CAUSED COMPLICATIONS IN HER LEGS. THE PARTY FURTHER STATED THEY ARE NOW HAVING DIFFICULTY WALKING DUE TO DEFECTIVE PRODUCTS. OTHER SURGICAL OR MEDICAL TREATMENT DETAILS PROVIDED INDICATES "ANOTHER HIP REPLACEMENT" NO FURTHER DETAILS KNOWN. (B)(6) 2024 REVISION REPORTED UNDER MDR#1038671-2024-03159.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692225 UNKNOWN HIP COMPONENTS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Other