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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 1; CEMENTLESS STEM
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MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED LAT STEM SIZE 1; CEMENTLESS STEM Back to Search Results
Catalog Number 01.18.141
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 09/18/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 october 2019: lot 124511: 50 items manufactured and released on 11-jan-2013.Expiration date: 2017-nov-30.No anomalies found related to the problem.To date, 42 items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
About 6 years and 4 months after primary the surgeon revised the patient hip for stem loosening.Stem and head replaced successfully.
 
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Brand Name
STEM: AMISTEM H HA COATED LAT STEM SIZE 1
Common Device Name
CEMENTLESS STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key9326061
Report Number3005180920-2019-00961
Device Sequence Number14021438
Product Code LZO
UDI-Device Identifier07630030804175
UDI-Public07630030804175
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K093944
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 11/15/2019
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 Date11/30/2017
Device Catalogue Number01.18.141
Device Lot Number124511
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/18/2019
Initial Report FDA Received Date11/15/2019
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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