BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPT FEMORAL STEM 12/14 NECK TAPER EXT. OFFSET SIZE 0 105 MM STEM LENGTH

    MDR report key: 19434812 · Received May 31, 2024

    Report

    Report Number
    0002648920-2024-00172
    Event Type
    Injury
    Date Received
    May 31, 2024
    Date of Event
    May 4, 2024
    Report Date
    August 28, 2024
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JDI
    PMA / PMN Number
    K191735
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 00877503203, ITEM NAME: BIOLOX DELTA, CERAMIC FEMORAL HEAD, L, 32/+3.5, TAPER 12/14, LOT #: 3032143. 00801102024, ITEM NAME: ALLEN MEDULLARY CEMENT PLUGS 1-24 MM DIAMETER FLANGE/12 MM DIAMETER CORE STORE IN COOL DRY PLACE, LOT #: 64563093. 00620205422, ITEM NAME: SHELL POROUS WITH CLUSTER HOLES 54 MM, LOT #: 64501093. 902581, ITEM NAME: 5.0 ALLTHREAD TI 2#2 MB TPRD N, LOT #: 677440. 00631005032, ITEM NAME: LINER 10 DEGREE ELEVATED RIM 32 MM I.D. FOR USE WITH 50/52/54 MM O.D. SHELLS, LOT #: 64629638. G2: AUSTRALIA. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT¿S LOCATION IS NOT KNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    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. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING; REVIEW OF FINDINGS FROM TIMELINE PROVIDED: PATIENT HAD A LIGHT FALL AT HOME. CT SCAN SHOWED FRACTURE AROUND MIDSHAFT. THE FRACTURE WAS FIXED WITH A PLATE. NO IMPLANTS HAVE BEEN EXPLANTED OR REMOVED. AN UNK ZIMMER NCB PP PLATE WAS IMPLANTED. REVIEW OF X-RAY IMAGES PROVIDED: IMPLANT FIT AND ALIGNMENT ARE MAINTAINED. BONE QUALITY APPEARS MILDLY OSTEOPENIC. THE ACETABULAR CUP ABDUCTION ANGLE MEASURES 42 DEGREES. THE FRACTURE CAN BE CONFIRMED ON THE CT IMAGE. THERE IS NO EVIDENCE OF IMPLANT LOOSENING OR MALALIGNMENT. OTHER THAN THE PERIPROSTHETIC FRACTURE, NO ADDITIONAL ABNORMALITY OR CONCERN IS IDENTIFIED. IMPLANT POSITION APPEARS NORMAL. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE 3 YEARS AND 3 MONTHS POST IMPLANTATION DUE TO A LIGHT FALL THAT RESULTED IN A PERI-PROSTHETIC FRACTURE. THE FRACTURE WAS FIXED WITH A PLATE AND ALL DEVICES REMAIN IMPLANTED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299290 CPT FEMORAL STEM 12/14 NECK TAPER EXT. OFFSET SIZE 0 105 MM STEM LENGTH PROSTHETIC, HIP JDI ZIMMER MANUFACTURING B.V. N/A 64627150

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention| H PLEASE SEE H11.