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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P STD SIZE 9; FEMORAL STEM CEMENTLESS
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MEDACTA INTERNATIONAL SA STEM: AMISTEM P STD SIZE 9; FEMORAL STEM CEMENTLESS Back to Search Results
Catalog Number 01.18.409
Date of Event 01/14/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 february 2021: lot 1908274: (b)(4) items manufactured and released on 05-feb-2020.Expiration date: 2025-01-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medacta medical affairs deprtment: few weeks after cementless total hip arthroplasty, the patient reported pain due to a femoral fracture.During rehabilitation period, a sudden movement on a weakened bone due to normal femoral preparation may favour the occurrence of early fracture.There is no reason to suspect a faulty device.
 
Event or Problem Description
Revision surgery performed after 2 months from the primary surgery due to a periprosthetic fracture.The surgeon revised the head and stem amistem-p with an m-vizion.The surgery was completed successfully.
 
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Brand Name
STEM: AMISTEM P STD SIZE 9
Common Device Name
FEMORAL STEM CEMENTLESS
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key11321539
Report Number3005180920-2021-00109
Device Sequence Number14488191
Product Code LZO
UDI-Device Identifier07630040720083
UDI-Public07630040720083
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K173794
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 02/12/2021
1 Device was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date01/25/2025
Device Catalogue Number01.18.409
Device Lot Number1908274
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/14/2021
Initial Report FDA Received Date02/12/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
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