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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM-P STD STEM SIZE 3; CEMENTLESS STEM
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MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM-P STD STEM SIZE 3; CEMENTLESS STEM Back to Search Results
Catalog Number 01.18.403
Health Effect - Clinical Code Hip Fracture (2349)
Date of Event 08/07/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 august 2020: lot 1909809: (b)(4) items manufactured and released on 24-mar-2020.Expiration date: 2025-03-15.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
The patient came in, 2 days after primary surgery, reporting pain due to a fractured femur.The cause of the fractured femur is unknown.The surgeon revised the stem, head, and liner.The surgery was completed successfully.
 
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Brand Name
STEM: AMISTEM P AMISTEM-P STD STEM SIZE 3
Common Device Name
CEMENTLESS STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key10486973
Report Number3005180920-2020-00581
Device Sequence Number16875200
Product Code LZO
UDI-Device Identifier07630040720021
UDI-Public07630040720021
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K173794
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 09/03/2020
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 Date03/15/2025
Device Catalogue Number01.18.403
Device Lot Number1909809
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/07/2020
Initial Report FDA Received Date09/03/2020
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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