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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM-P STD STEM SIZE 6; HIP STEM
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MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM-P STD STEM SIZE 6; HIP STEM Back to Search Results
Catalog Number 01.18.406
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 10/30/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 november 2019.Lot 182534: 40 items manufactured and released on 25-jul-2018.Expiration date: 2023-07-16.No anomalies found related to the problem.To date, 30 items of the same lot have been already sold without any other similar reported event.
 
Event or Problem Description
The patient came in complaining of pain due to a potted stem.The cause of the potted stem is unknown.The surgeon revised the stem and head almost 7 months after primary.The surgery was completed successfully.
 
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Brand Name
STEM: AMISTEM P AMISTEM-P STD STEM SIZE 6
Common Device Name
HIP STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key9394959
Report Number3005180920-2019-00998
Device Sequence Number13949456
Product Code LZO
UDI-Device Identifier07630040720052
UDI-Public07630040720052
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K173794
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date (Section B) 02/25/2020
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 Date07/16/2023
Device Catalogue Number01.18.406
Device Lot Number182534
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/30/2019
Supplement Date Received by Manufacturer10/30/2019
Initial Report FDA Received Date12/02/2019
Supplement Report FDA Received Date02/25/2020
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;
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