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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM C CEMENTED STD STEM SIZE 5; CEMENTED HIP STEM
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MEDACTA INTERNATIONAL SA AMISTEM C CEMENTED STD STEM SIZE 5; CEMENTED HIP STEM Back to Search Results
Catalog Number 01.18.155
Health Effect - Clinical Code No Code Available (3191)
Date of Event 08/12/2016
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2018: lot 156208: (b)(4) items manufactured and released on january 15, 2016.Expiration date: 01/02/2021.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
On (b)(6) 2018 the sales representative has been informed by the surgeon that a revision surgery was performed.At this time we do not know if the reason of the revision surgery is bone fracture or stem loosening.
 
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Brand Name
AMISTEM C CEMENTED STD STEM SIZE 5
Common Device Name
CEMENTED HIP STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key7291621
Report Number3005180920-2018-00086
Device Sequence Number13788803
Product Code LZO
UDI-Device Identifier07630030804304
UDI-Public07630030804304
Combination Product (Y/N)N
Initial Reporter CountrySZ
PMA/510(K) Number
K103189
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2016
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 02/23/2018
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 Date01/02/2021
Device Catalogue Number01.18.155
Device Lot Number156208
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/24/2018
Initial Report FDA Received Date02/23/2018
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 Age80 YR
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