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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM HA COATED STD STEM SIZE 7; UNCEMENTED HIP STEM
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MEDACTA INTERNATIONAL SA AMISTEM HA COATED STD STEM SIZE 7; UNCEMENTED HIP STEM Back to Search Results
Catalog Number 01.18.137
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 12/17/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 december 2019: lot 150868: (b)(4) items manufactured and released on 11-jun-2015.Expiration date: 2020-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event.
 
Event or Problem Description
The patient came in complaining of pain due to a loose stem.The surgeon revised the stem and head with another company's product and revised the liner with a medacta liner.The surgery was completed successfully.
 
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Brand Name
AMISTEM HA COATED STD STEM SIZE 7
Common Device Name
UNCEMENTED HIP STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key9590199
Report Number3005180920-2019-01142
Device Sequence Number18955543
Product Code LZO
UDI-Device Identifier07630030804137
UDI-Public07630030804137
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K093944
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) 01/15/2020
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 Date04/30/2020
Device Catalogue Number01.18.137
Device Lot Number150868
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/17/2019
Initial Report FDA Received Date01/15/2020
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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