BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM UNI 12/14 TPR SLV + 0

    MDR report key: 13012912 · Received December 15, 2021

    Report

    Report Number
    1020279-2021-08688
    Event Type
    Injury
    Date Received
    December 15, 2021
    Date of Event
    November 27, 2021
    Report Date
    January 19, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LZY
    UDI-DI
    03596010196545
    PMA / PMN Number
    K896580
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    H3, H6: THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE PICTURES PROVIDED WERE REVIEWED AND COULD NOT CONFIRM THE STATED FAILURE MODE. THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE CORROBORATED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT, THE TWO UNDATED PHOTOS OF X-RAYS WERE REVIEWED. HOWEVER, THEY DO NOT AID IN THE CLINICAL INVESTIGATION OF THE REPORTED INFECTION. THEREFORE, BASED ON INSUFFICIENT INFORMATION, A THOROUGH MEDICAL ASSESSMENT COULD NOT BE PERFORMED AT THIS TIME. SHOULD ANY ADDITIONAL RELEVANT CLINICAL INFORMATION BE PROVIDED, THIS COMPLAINT WOULD BE RE-ASSESSED. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. 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 REVIEW OF THE STERILIZATION RECORDS REVEALED THE BATCH WAS STERILIZED WITHIN NORMAL PARAMETERS. AN 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, AFTER A THR SURGERY PERFORMED ON (B)(6) 2021, DUE TO INFECTION A TWO STAGES REVISION SURGERY WAS PERFORMED. ON THE FIRST STAGE THE TANDEM UNIPOLAR HEAD 54MM ((B)(4)), THE TANDEM UNIPOLAR 12/14 TAPER SLEEVE + 0 ((B)(4)) AND THE SPECTRON EF 12/14 TAPER LONG STRAIGHT 225MM SMALL ((B)(4)) WERE EXPLANTED AND A REVISION LONG STEM SPECTRON WITH A TANDEM UNIPOLAR HEAD, COATED IN ANTIBIOTIC CEMENT WERE PLACED INTO THE PATIENT. THE SECOND STAGE REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO EXTRACT THE DEVICES THAT WERE PUT IN ON THE FIRST STAGE SURGERY AND TO EXCHANGE THEM WITH THE IMPLANTS. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED ON (B)(6) 2021, THE PATIENT HAD AN INFECTION. A TWO STAGES REVISION SURGERY WAS PERFORMED IN ORDER TO SOLVE THIS ADVERSE EVENT. ON THE FIRST STAGE, THE TANDEM UNIPOLAR HEAD 54MM (B)(4), THE TANDEM UNIPOLAR 12/14 TAPER SLEEVE + 0 (B)(4) AND THE SPECTRON EF 12/14 TAPER LONG STRAIGHT 225MM SMALL ((B)(4)) WERE EXPLANTED AND A REVISION LONG STEM SPECTRON WITH A TANDEM UNIPOLAR HEAD, COATED IN ANTIBIOTIC CEMENT WERE PLACED INTO THE PATIENT. THE SECOND STAGE REVISION SURGERY WAS PERFORMED ON 27-NOV-2021 TO EXTRACT THE DEVICES THAT WERE PUT IN ON THE FIRST STAGE SURGERY AND TO EXCHANGE THEM WITH THE IMPLANTS. A REDAPT MODULAR ACETABULAR COMPONENT WITH 225 LONG STEM SPECTRON WERE IMPLANTED. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1910596 TANDEM UNI 12/14 TPR SLV + 0 PROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALL LZY SMITH & NEPHEW, INC. 71326600 21EM00400 03596010196545

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown