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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED STD STEM SIZE 7; CEMENTLESS STEM
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MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED STD STEM SIZE 7; CEMENTLESS STEM Back to Search Results
Catalog Number 01.18.137
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 07/01/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on (b)(6) 2019: lot 150868: (b)(4) items manufactured and released on 11-jun-2015.Expiration date: 2020-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
Revision surgery performed after 3 years and 4 months from the primary due to pain caused by distally potted stem and loose proximally.The surgeon revised the stem, head and liner.The surgery was completed successfully.
 
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Brand Name
STEM: AMISTEM H HA COATED STD STEM SIZE 7
Common Device Name
CEMENTLESS STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key8836268
Report Number3005180920-2019-00621
Device Sequence Number11396580
Product Code LZO
UDI-Device Identifier07630030804137
UDI-Public07630030804137
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K093944
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/29/2019
1 Device was Involved in the Event
1 Patient 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 Date04/30/2020
Device Catalogue Number01.18.137
Device Lot Number150868
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/01/2019
Initial Report FDA Received Date07/29/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age54 YR
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