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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM-P COLLARED STD STEM SIZE 2; CEMENTLESS HIP STEM
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MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM-P COLLARED STD STEM SIZE 2; CEMENTLESS HIP STEM Back to Search Results
Catalog Number 01.18.432
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 1907539: (b)(4) items manufactured and released on 26-nov-2019.Expiration date: 2024-11-16.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 1 month after the primary surgery reporting instability due to a subsided stem.The surgeon revised the stem, linear, and head.The surgery was completed successfully.
 
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Brand Name
STEM: AMISTEM P AMISTEM-P COLLARED STD STEM SIZE 2
Common Device Name
CEMENTLESS HIP STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key10343414
Report Number3005180920-2020-00486
Device Sequence Number13659146
Product Code LZO
UDI-Device Identifier07630040720212
UDI-Public07630040720212
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) 07/30/2020
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 Date11/16/2024
Device Catalogue Number01.18.432
Device Lot Number1907539
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 Date07/30/2020
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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