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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM C CEMENTED STD SIZE 3; CEMENTED FEMORAL STEM
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MEDACTA INTERNATIONAL SA STEM: AMISTEM C CEMENTED STD SIZE 3; CEMENTED FEMORAL STEM Back to Search Results
Model Number 01.18.153
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 01/11/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08-feb-2021: lot 181661: (b)(4) items manufactured and released on 19-jun-2018.Expiration date: 2023-jun-10.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.
 
Event or Problem Description
Revision surgery performed due to stem mobilization 2 years after the primary surgery.
 
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Brand Name
STEM: AMISTEM C CEMENTED STD SIZE 3
Common Device Name
CEMENTED FEMORAL STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key11307454
Report Number3005180920-2021-00094
Device Sequence Number3374497
Product Code LZO
UDI-Device Identifier07630030804281
UDI-Public07630030804281
Combination Product (Y/N)N
Initial Reporter CountrySZ
PMA/510(K) Number
K103189
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) 02/10/2021
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 Date06/10/2023
Device Model Number01.18.153
Device Catalogue Number01.18.153
Device Lot Number181661
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/11/2021
Initial Report FDA Received Date02/10/2021
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 Age60 YR
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