BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LOW PROFILE SCREW 6.5X15MM

    MDR report key: 16910616 · Received May 11, 2023

    Report

    Report Number
    0001825034-2023-01019
    Event Type
    Injury
    Date Received
    May 11, 2023
    Date of Event
    September 10, 2020
    Report Date
    September 15, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K991807
    Removal / Correction Number
    N/A
    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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED FINDINGS OF THE REPORTED ISSUES. FAILED LEFT TOTAL HIP ARTHROPLASTY WITH LINER FRACTURE/DISASSOCIATION. ACUTE ONSET OF PAIN, DISASSOCIATION WITH WELL-FIXED ACETABULAR COMPONENT. EVIDENCE OF METALLOSIS BETWEEN THE HEAD AND SHELL. POLY LINER BROKEN INTO 5 PIECES AND DEMONSTRATES WEAR. THE COMPLAINT WAS CONFIRMED; HOWEVER, THE REPORTED ISSUES RELATE TO THE LINER/HEAD DISLOCATION AND LINER FRACTURE. THE TI LOW PROFILE SCREW 6.5X15MM WAS UNRELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-01015, 0001825034-2023-01016, 0001825034-2023-01018. D10: CAT# 15-103203 LOT# 565060 TAPERLOC MICROP LAT FMRL 9.0MM, CAT# 12-104152 LOT# 447270 M/H RADIAL 3-HOLE SHELL 52MM, CAT# EP-108223 LOT# 279030 E-POLY 36MM +3 MAXROM LNR SZ23, CAT# 650-1057 LOT# 130640 CER BIOLOXD OPTION HD 36MM, CAT# 103531 LOT# 921530 TI LOW PROFILE SCREW 6.5X20MM.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL LEFT TOTAL HIP ARTHROPLASTY. APPROXIMATELY SIX YEARS POST-OP, THE PATIENT HAD AN ACUTE ONSET OF PAIN AND LIMITED MOBILITY. RADIOGRAPHIC IMAGING DISPLAYED ACETABULAR DISSOCIATION. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION, WHERE EVIDENCE OF METALLOSIS WAS NOTED BETWEEN THE FEMORAL HEAD ARTICULATING AGAINST THE METAL ACETABULAR SHELL, AND THE POLY LINER WAS FOUND BROKEN IN FIVE PIECES WITH WEAR. ALL COMPONENTS, EXCEPT FOR THE STEM, WERE REVISED. THERE WERE NO REPORTED INTRA-OPERATIVE COMPLICATIONS. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1638398 TI LOW PROFILE SCREW 6.5X15MM PROTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 939650

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention| H