BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REF THREE HOLE SHELL 52MM

    MDR report key: 13080860 · Received December 23, 2021

    Report

    Report Number
    1020279-2021-08837
    Event Type
    Injury
    Date Received
    December 23, 2021
    Date of Event
    December 3, 2021
    Report Date
    January 27, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MBL
    UDI-DI
    03596010454355
    PMA / PMN Number
    K960094
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE REPORTED EVENT COULD NOT BE CONFIRMED. THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE CORROBORATED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT, SMITH AND NEPHEW HAS NOT RECEIVED THE EXPLANTED DEVICE AND/OR ADEQUATE MATERIALS TO FULLY EVALUATE THE COMPLAINT. IF ADDITIONAL CLINICALLY RELEVANT MATERIALS ARE LATER RECEIVED, THEN THE CASE MAY BE RE-OPENED FOR FURTHER EVALUATION. A REVIEW OF COMPLAINT HISTORY DID NOT REVEAL SIMILAR EVENTS FOR THE LISTED DEVICE. A REVIEW OF THE RISK MANAGEMENT FILE REVEALED THIS FAILURE MODE WAS PREVIOUSLY IDENTIFIED. THE ANTICIPATED RISK LEVEL IS STILL ADEQUATE. THE INSTRUCTIONS FOR USE DOCUMENTS REVEALED THIS FAILURE MODE WAS PREVIOUSLY IDENTIFIED. A HISTORICAL REVIEW CONCLUDED THAT THERE ARE NO PRIOR ACTIONS RELATED TO THIS PRODUCT AND EVENT. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. POSSIBLE CAUSES COULD INCLUDE BUT ARE NOT LIMITED TO CONTAMINATION, PATIENT REACTION, AND POST-OPERATIVE HEALING ISSUE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. WITHOUT THE RETURN OF THE ACTUAL PRODUCT INVOLVED, OUR INVESTIGATION COULD NOT PROCEED. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, AFTER A THR SURGERY, THE PATIENT PRESENTED AN INFECTION, SO A FIRST STAGE REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO REMOVE AND REPLACE AN UNKNOWN REFLECTION LINER ((B)(4)), A SPECTRON EF PRIMARY HIGH OFFSET 12/14 FEM SZ 3 ((B)(4)), A COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0 ((B)(4)) AND A REFLECTION THREE HOLE SHELL SIZE 52MM ((B)(4)). CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1971509 REF THREE HOLE SHELL 52MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS MBL SMITH & NEPHEW, INC. 71336452 UNK 03596010454355

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown