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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 STEM SIZE 5; HIP CEMENTLESS STEM
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MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED LAT STEM SIZE 5; HIP CEMENTLESS STEM Back to Search Results
Catalog Number 01.18.145
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 03/25/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 april 2019: lot 154526: (b)(4) items manufactured and released on 20-jan-2016.Expiration date: 2021-01-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
Revision surgery after 2 years and 11 months from the primary due to pain caused by an aseptic loosening of the stem.The surgeon revised the stem and head with another company's product and revised the liner.The surgery was completed successfully.
 
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Brand Name
STEM: AMISTEM H HA COATED LAT STEM SIZE 5
Common Device Name
HIP CEMENTLESS STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key8544430
Report Number3005180920-2019-00304
Device Sequence Number2443750
Product Code LZO
UDI-Device Identifier07630030804212
UDI-Public07630030804212
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K093944
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 04/24/2019
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 Date01/06/2021
Device Catalogue Number01.18.145
Device Lot Number154526
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/25/2019
Initial Report FDA Received Date04/24/2019
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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