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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 00; CEMENTLESS STEM
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MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED STD STEM SIZE 00; CEMENTLESS STEM Back to Search Results
Model Number 01.18.098
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 03/25/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 01 april 2021: lot 122915: (b)(4) items manufactured and released on 02-oct-2012.Expiration date: 2017-08-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold.No other similar events have been reported on this lot since 2017.
 
Event or Problem Description
Revision surgery performed due to stem mobilization 4 years after the primary.The surgeon revised successfully the stem and head.
 
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Brand Name
STEM: AMISTEM H HA COATED STD STEM SIZE 00
Common Device Name
CEMENTLESS STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key11706279
Report Number3005180920-2021-00322
Device Sequence Number3018772
Product Code LZO
UDI-Device Identifier07630030803765
UDI-Public07630030803765
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K121011
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 04/22/2021
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 Date08/31/2017
Device Model Number01.18.098
Device Catalogue Number01.18.098
Device Lot Number122915
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/25/2021
Initial Report FDA Received Date04/22/2021
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 Age42 YR
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