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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
Medical Device Problem Code Migration (4003)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 08/02/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06.August.2021 lot 1908266: (b)(4) items manufactured and released on 22-gen-2020.Expiration date: 2025-01-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without a similar reported event.
 
Event or Problem Description
10 months after the primary surgery the patient came in reporting pain due to a subsided stem and the cause of the subsided stem is unknown.The surgeon revised the stem and head and the surgery was completed successfully.
 
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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 Key12390511
Report Number3005180920-2021-00692
Device Sequence Number20105660
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 Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 08/31/2021
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 Date01/07/2025
Device Catalogue Number01.18.403
Device Lot Number1908266
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/02/2021
Initial Report FDA Received Date08/31/2021
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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