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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H HA COATED LAT STEM SIZE 5; CEMENTLESS HIP STEM
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MEDACTA INTERNATIONAL SA AMISTEM H HA COATED LAT STEM SIZE 5; CEMENTLESS HIP STEM Back to Search Results
Catalog Number 01.18.145
Medical Device Problem Code Packaging Problem (3007)
Health Effect - Clinical Code No Information (3190)
Date of Event 04/18/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Batch review performed on 17-may-2018.Lot 162262: (b)(4) items manufactured and released on 06-july-2016.Expiration date: 2021-06-23.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
Stem was found to be loose inside packaging.This caused coating detachment.A stem back-up was used, the packaging was scratched.
 
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Brand Name
AMISTEM H HA COATED LAT STEM SIZE 5
Common Device Name
CEMENTLESS HIP STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key7525807
Report Number3005180920-2018-00341
Device Sequence Number11076272
Product Code LZO
UDI-Device Identifier07630030804212
UDI-Public07630030804212
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K093944
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date06/23/2021
Device Catalogue Number01.18.145
Device Lot Number162262
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/18/2018
Initial Report FDA Received Date05/18/2018
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 Other;
Patient Age65 YR
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