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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM C, CEMENTED STEM SIZE 1 STD; CEMENTED FEMORAL STEM
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MEDACTA INTERNATIONAL SA AMISTEM C, CEMENTED STEM SIZE 1 STD; CEMENTED FEMORAL STEM Back to Search Results
Catalog Number 01.18.151
Health Effect - Clinical Code Joint Disorder (2373)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 october 2017.Lot 121355: (b)(4) items manufactured and released on 25 april 2012.Expiration date: 2017-03-31.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
The patient came in complaining of instability.The surgeon determined the stem was loose.The cause of the loosening is unknown.The surgeon revised the stem only and re-implanted a size 0 stem.The surgery was completed successfully.
 
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Brand Name
AMISTEM C, CEMENTED STEM SIZE 1 STD
Common Device Name
CEMENTED FEMORAL STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key6921409
Report Number3005180920-2017-00560
Device Sequence Number898940
Product Code JDI
UDI-Device Identifier07630030804267
UDI-Public07630030804267
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K103189
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2017
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/06/2017
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 Date03/31/2017
Device Catalogue Number01.18.151
Device Lot Number121355
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/08/2017
Initial Report FDA Received Date10/06/2017
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 Age73 YR
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