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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 HIP STEM
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MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM-P STD STEM SIZE 3; CEMENTLESS HIP STEM Back to Search Results
Catalog Number 01.18.403
Health Effect - Clinical Code No Code Available (3191)
Date of Event 02/14/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 february 2020: lot 1901562: 143 items manufactured and released on 22-may-2019.Expiration date: 2024-05-07.No anomalies found related to the problem.To date, 118 items of the same lot have been already sold without any similar event reported.
 
Event or Problem Description
About 2 weeks after primary surgery the surgeon revised the patient knee for a suspected infection.The surgeon observed that the patient had excessive drainage of the incision area.During the surgery it was observed that the femur was fractured.The surgeon cabled the fracture, the infection is finally not confirmed.
 
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Brand Name
STEM: AMISTEM P AMISTEM-P STD STEM SIZE 3
Common Device Name
CEMENTLESS HIP STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key9822923
Report Number3005180920-2020-00143
Device Sequence Number3037116
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 company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 03/12/2020
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 Date05/07/2024
Device Catalogue Number01.18.403
Device Lot Number1901562
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/12/2020
Initial Report FDA Received Date03/12/2020
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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