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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM COLLARED STEM HA COATED STD SIZE 2; UNCEMENTED HIP STEM
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MEDACTA INTERNATIONAL SA STEM: AMISTEM COLLARED STEM HA COATED STD SIZE 2; UNCEMENTED HIP STEM Back to Search Results
Catalog Number 01.18.232
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 09/23/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2019: lot 161473: 15 items manufactured and released on 22-jun-2016.Expiration date: 2021-05-31.No anomalies found related to the problem.To date, 15 items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
The patient came in, about three years after primary surgery, complaining of pain due to a loose femoral stem.The surgeon revised the stem, head and liner.The surgery was completed successfully.
 
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Brand Name
STEM: AMISTEM COLLARED STEM HA COATED STD SIZE 2
Common Device Name
UNCEMENTED HIP STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key9222732
Report Number3005180920-2019-00888
Device Sequence Number1564693
Product Code LZO
UDI-Device Identifier07630030804571
UDI-Public07630030804571
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K121011
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/23/2019
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 Date05/31/2021
Device Catalogue Number01.18.232
Device Lot Number161473
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/23/2019
Initial Report FDA Received Date10/23/2019
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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