BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPACT FLAT PE HC LINER Ø28/B

    MDR report key: 5354242 · Received January 8, 2016

    Report

    Report Number
    3005180920-2015-00366
    Event Type
    Malfunction
    Date Received
    January 8, 2016
    Date of Event
    December 10, 2015
    Report Date
    April 8, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    PMA / PMN Number
    K103721
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 29 DEC 2015, THE MEDICAL AFFAIRS PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: FEW COMMENTS ARE POSSIBLE FROM THE CLINICAL POINT OF VIEW. IT IS IMPORTANT THAT THE DIMENSIONAL ANALYSIS IS CARRIED OUT. CEMENTATION OF A VERSAFIT CUP IS NOT A SEVERE CONTRAINDICATION, ALTHOUGH NOT RECOMMENDED. THE ROOT CAUSE FOR DIFFICULTY IN ASSEMBLY CANNOT BE DETERMINED FROM THE CLINICAL PERSPECTIVE WITH THE AVAILABLE INFORMATION. ON 21 DEC 2105, THE R&D PERFORMED A PRELIMINARY INVESTIGATION OF THE RETRIEVED ITEM AND COMMENT AS FOLLOWS: THE REASON WHY A LINER CAN STRUGGLE TO FIT DEPENDS ONLY ON THE CLEANING OF THE METALBACK ONCE IMPLANTED. IN OPERATIVE TECHNIQUE WE SAY TO CLEAN AND DRY THE SHELL OF TITANIUM BEFORE IMPLANTING THE PE. OF COURSE, PROVIDED THAT ALL COMPONENTS MEET THE SPECIFICATIONS. THE NON-HA COATED METALBACK CAN BE CEMENTED AT THE LAST, I SEE NO PROBLEMS IN THIS REGARD. ONLY WITH THE RECEIPT OF THE INDICTED PIECES WE CAN TRY TO MAKE OTHER CONSIDERATIONS. BATCH REVIEW PERFORMED ON 05 JANUARY 2016: LOT 140546: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 OCTOBER 2014. EXPIRATION DATE: 2019-08-31. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MPACT CUP ACETABULAR SHELL Ø46 TWO-HOLES, CODE 01.32.146DH LOT. 133658 (K132879): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 FEBRUARY 2014. EXPIRATION DATE: 2019-01-31. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MPACT LINER HOODED PE HC LINER Ø28/B, CODE 01.32.2837HCAT, LOT. 145273 (K132879): 24 ITEMS MANUFACTURED AND RELEASED ON 27 OCTOBER 2014. EXPIRATION DATE: 2019-09-30. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, 1 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ON 22 DECEMBER 2015 THE R&D MANAGER ANALYSED THE RETURNED IMPLANT: OBSERVING THE POLYETHYLENE LINER NO PARTICULAR SIGN CAN BE NOTED. ON 08 JANUARY 2016 THE QUALITY CONTROL MANAGER MEASURED THE RETRIEVED LINER WITH THE FOLLOWING ANALYSIS: "THE INVESTIGATION CONFIRMED THAT THE DEVICE HAS BEEN PRODUCED ACCORDING TO THE SPECIFICATION VALID AT THE TIME OF MANUFACTURE."

    Additional Manufacturer Narrative · 1

    ON 09MAR2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 14MAR2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    THE SURGEON FIRSTLY IMPLANTED MPACT SHELL INTO THE PATIENT. THEN HE TRIED TO IMPLANT THE FLAT LINER WITH NORMAL IMPACTION, BUT THE FLAT LINER DID NOT FIT INTO THE SHELL. THEN HE TRIED TO IMPLANT MORE STRONGLY, BUT IT DID NOT FIT. THIS TIMING THE PATIENT'S PELVIS BONE MIGHT BE FRACTURED. HE RETRIEVED IMPLANTED MPACT SHELL FROM THE PATIENT AND TRIED TO FIT THE FLAT LINER INTO RETRIEVED MPACT SHELL, BUT HE COULDN'T. HE DECIDED TO REPLACE THE FLAT LINER WITH THE NEW HOODED LINER, BUT IT DID NOT FIT. HE TRIED TO FIT NEW HOODED LINER MANY TIMES AND EVENTUALLY NEW HOODED LINER FIT INTO THE MPACT SHELL. DUE TO THE PATIENT PELVIS BONE MIGHT BE FRACTURED, HE DECIDED TO FIX MPACT SHELL WITH NEW HOODED LINER WITH BONE CEMENT INTO THE PATIENT. EVENTUALLY, HE COULD IMPLANT MPACT SHELL WITH NEW HOODED LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12297 MPACT FLAT PE HC LINER Ø28/B HIP PROSTHESIS LINER LPH MEDACTA INTERNATIONAL SA 140546

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other