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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 5; HIP CEMENTLESS STEM
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MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM-P STD STEM SIZE 5; HIP CEMENTLESS STEM Back to Search Results
Catalog Number 01.18.405
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 07/09/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 21 july 2020: lot 183747: (b)(4) items manufactured and released on 09-oct-2018.Expiration date: 2023-09-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any other similar reported event.
 
Event or Problem Description
The patient came in 1year and 3 months after the primary surgery reporting thigh pain which was caused by a loose stem.The surgeon revised the medacta stem and head with another company's product and revised the medacta liner with a medacta liner.The surgery was completed successfully.
 
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Brand Name
STEM: AMISTEM P AMISTEM-P STD STEM SIZE 5
Common Device Name
HIP CEMENTLESS STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874, CHE
SZ  6874, CHE
MDR Report Key10366565
Report Number3005180920-2020-00487
Device Sequence Number16730557
Product Code LZO
UDI-Device Identifier07630040720045
UDI-Public07630040720045
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K173794
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/05/2020
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 No Information
Device Expiration Date09/25/2023
Device Catalogue Number01.18.405
Device Lot Number183747
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/09/2020
Initial Report FDA Received Date08/05/2020
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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