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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 0; FEMORAL CEMENTLESS STEM
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MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED LAT SIZE 0; FEMORAL CEMENTLESS STEM Back to Search Results
Model Number 01.18.140
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 02/10/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11-mar-2021: lot 135041: (b)(4) items manufactured and released on 11-dec-2013.Expiration date: 2018-11-30.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 since 2017.
 
Event or Problem Description
Revision surgery performed due to stem loosening 2 years and 10 months after the primary surgery.The patient already underwent revision surgery due to infection.
 
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Brand Name
STEM: AMISTEM H HA COATED LAT SIZE 0
Common Device Name
FEMORAL CEMENTLESS STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key11462518
Report Number3005180920-2021-00187
Device Sequence Number4189984
Product Code LZO
UDI-Device Identifier07630030804168
UDI-Public07630030804168
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K121011
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
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) 03/11/2021
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 Date11/30/2018
Device Model Number01.18.140
Device Catalogue Number01.18.140
Device Lot Number135041
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/10/2021
Initial Report FDA Received Date03/11/2021
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;
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