BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEDGE PLASMA S/O SZ 5

    MDR report key: 16613004 · Received March 24, 2023

    Report

    Report Number
    1038671-2023-00505
    Event Type
    Injury
    Date Received
    March 24, 2023
    Date of Event
    February 27, 2023
    Report Date
    February 17, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862250773
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS G3, G6, H2, H3 AND H6 HAVE BEEN UPDATED ACCORDINGLY. (H3) AS REPORTED, APPROXIMATELY TWENTY-SIX DAYS POST INITIAL RIGHT THA, THE69 Y/O FEMALE PATIENT WAS BROUGHT BACK FOR RIGHT HIP PAIN. SALES REP WAS UNAWARE IF PATIENT FELL OR HAD ANY TYPE OF TRAUMA TO THE HIP. SHE FRACTURED HER LESSER TROCHANTER. THE HIP WAS DISLOCATED, THE FEMORAL HEAD AND STEM REMOVED. THE FRACTURE WAS REDUCED WITH THE USE OF A CABLE SYSTEM. THE POLY LINER WAS REMOVED WITH THE HELP OF A BONE SCREW. A NEW G4 ALTEON 36MM LINER WAS IMPLANTED AND A LONG SMITH AND NEPHEW HIP STEM WAS CEMENTED IN PLACE. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOW TO BE INSTABLE CONDITION FOLLOWING THE EVENT. PHOTOS AND X-RAY RECEIVED, THE DEVICES ARE AVAILABLE FOR EVALUATION. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION REGARDING FRACTURE. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: ALT XLE LNR EXTCOV G4 36 (CAT# 01-030-42-0436 / SERIAL# (B)(4)); BIOLOX DELTA FEMORAL HEAD 36MM OD, +3.5MM (CAT# 170-36-03 / SERIAL# (B)(4)). ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY TWENTY-SIX DAYS POST INITIAL RIGHT THA, THE 69 Y/O FEMALE PATIENT WAS BROUGHT BACK FOR RIGHT HIP PAIN. SALES REP WAS UNAWARE IF PATIENT FELL OR HAD ANY TYPE OF TRAUMA TO THE HIP. SHE FRACTURED HER LESSER TROCH. THE HIP WAS DISLOCATED, THE FEMORAL HEAD AND STEM REMOVED. THE FRACTURE WAS REDUCED WITH THE USE OF A CABLE SYSTEM. THE POLY LINER WAS REMOVED WITH THE HELP OF A BONE SCREW. A NEW G4 ALTEON 36MM LINER WAS IMPLANTED AND A LONG SMITH AND NEPHEW HIP STEM WAS CEMENTED IN PLACE. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOW TO BE INSTABLE CONDITION FOLLOWING THE EVENT. PHOTOS AND X-RAY RECEIVED, THE DEVICES ARE AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583354 WEDGE PLASMA S/O SZ 5 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. WEDGE PLASMA S/O SZ 5 UNK 10885862250773

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention ALT CUP CLSTR G3 SZ 48| ALT CUP CLSTR G4 SZ 50| ALT XLE LNR EXTCOV G3 32| ALTEON 6.5MM SCREW, 35MM (2)