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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 0; UNCEMENTED HIP STEM
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MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED STD STEM SIZE 0; UNCEMENTED HIP STEM Back to Search Results
Catalog Number 01.18.130
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 03/19/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 april 2019: lot 111243: (b)(4) items manufactured and released on 25-may-2011.Expiration date: 2016-04-30.No anomalies found related to the problem.To date, all the items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
The patient came in complaining of pain caused by a loose stem 6 years and 9 months after primary.The surgeon revised the stem and head with another company's product and revised the liner with a medacta liner.The surgery was completed successfully.
 
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Brand Name
STEM: AMISTEM H HA COATED STD STEM SIZE 0
Common Device Name
UNCEMENTED HIP STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key8527541
Report Number3005180920-2019-00288
Device Sequence Number13924166
Product Code LZO
UDI-Device Identifier07630030804069
UDI-Public07630030804069
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K093944
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Device Explanted Year2019
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 04/18/2019
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 Date04/30/2016
Device Catalogue Number01.18.130
Device Lot Number111243
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/20/2019
Initial Report FDA Received Date04/18/2019
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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