BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVATION

    MDR report key: 24573585 · Received March 11, 2026

    Report

    Report Number
    1038671-2026-00248
    Event Type
    Injury
    Date Received
    March 11, 2026
    Date of Event
    November 24, 2025
    Report Date
    March 10, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    MEH
    UDI-DI
    10885862207074
    PMA / PMN Number
    K121392
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 180-11-48 - NV CROWN CUP CLSR HL W/HA 48MM GROUP 1: (B)(6) 164-03-08 - ELEMENT-STEM, COLLARED W/HA, STD OFFSET, SZ 8: (B)(6) 01-032-03-3294 - UNIVERSAL CUP, HEAD, DELTA, 32MM, -4: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 65 YO FEMALE PATIENT, WHO HAD AN INITIAL LEFT THA, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 6 YEARS POST THE INITIAL PROCEDURE. PE WEAR + MICROPARTICLE DISEASE, PAIN DURING HIP ROTATIONS REPORTED. THE CUP WITH A MODEL G7 50 PROSTHESIS, WITH A CERAMIC-CERAMIC 32 L FRICTION PAIR WERE REPLACED. THE CYSTIC AREAS WERE FILLED WITH BONE GRAFT. INTRAOPERATIVE CULTURES ARE NEGATIVE. HAVING FOLLOWED A SATISFACTORY EVOLUTION, HE BEGAN AMBULATION 48 HOURS AFTER SURGERY WITHOUT COMPLICATIONS AND WAS DISCHARGED. FAVORABLE EVOLUTION, SATISFACTORY FROM AN ORTHOPEDIC STANDPOINT; AMBULATION WITH TWO CRUTCHES INDICATED. NO FURTHER INFORMATION. ADDITIONAL INFORMATION RECEIVED 2/20/2026: INVOICE RELATED TO THE SURGERY PERFORMED ON (B)(6) 2019 (MEDICAL RECORD NO. (B)(6) / CIC NO. (B)(6), INCLUDING THE PRODUCT REFERENCE NUMBERS AND THE CORRESPONDING LOT/SERIAL NUMBERS. IMPLANT REGISTER AND TRACEABILITY SHEET FOR THE REVISION SURGERY ON (B)(6) 2025 (MEDICAL RECORD NO. (B)(6) / CIC NO. (B)(6), INCLUDING THE IMPLANT LABELS FOR THE IMPLANTED MATERIAL. REF B076.1713.000.00 CERAMIC HEAD 32MM L 12/14 CONE SN: (B)(6). MATERIAL: BIO CERAMIC. SUSPECT DEVICE(S): 130-32-51 - NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS: (B)(6) CONCOMITANTS: 180-11-48 - NV CROWN CUP CLSR HL W/HA 48MM GROUP 1: (B)(6) 164-03-08 - ELEMENT-STEM, COLLARED W/HA, STD OFFSET, SZ 8: (B)(6) 01-032-03-3294 - UNIVERSAL CUP, HEAD, DELTA, 32MM, -4: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222874 NOVATION PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU MEH EXACTECH, INC. 10885862207074

    Patients

    Seq Age Sex Outcome Treatment
    1