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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED LAT SIZE 5; CEMENTLESS FEMORAL STEM
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MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED LAT SIZE 5; CEMENTLESS FEMORAL STEM Back to Search Results
Model Number 01.18.145
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 01/05/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29-jan-2021: lot 157341: (b)(4) items manufactured and released on 26-apr-2016.Expiration date: 2021-apr-03.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event.
 
Event or Problem Description
Revision surgery after about 2 years after the primary surgery due to neck stem breakage.No additional information is available at the moment.
 
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Brand Name
STEM: AMISTEM H HA COATED LAT SIZE 5
Common Device Name
CEMENTLESS FEMORAL STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key11371538
Report Number3005180920-2021-00134
Device Sequence Number4037366
Product Code LZO
UDI-Device Identifier07630030804212
UDI-Public07630030804212
Combination Product (Y/N)N
Initial Reporter CountryIT
PMA/510(K) Number
K093944
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
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) 02/24/2021
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 Date04/03/2021
Device Model Number01.18.145
Device Catalogue Number01.18.145
Device Lot Number157341
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/25/2021
Initial Report FDA Received Date02/24/2021
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 Age80 YR
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