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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM P 01.18.402 AMISTEM-P STD STEM SIZE 2; HIP STEM
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MEDACTA INTERNATIONAL SA AMISTEM P 01.18.402 AMISTEM-P STD STEM SIZE 2; HIP STEM Back to Search Results
Catalog Number 01.18.402
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 06/22/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 july 2021: lot 2007164: (b)(4) items manufactured and released on 12-oct-2020.Expiration date: 2025-09-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
 
Event or Problem Description
Revision surgery for stem loosening 3 months after primary thr.The surgery was completed successfully, stem and head revised successfully.
 
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Brand Name
AMISTEM P 01.18.402 AMISTEM-P STD STEM SIZE 2
Common Device Name
HIP STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key12210365
Report Number3005180920-2021-00586
Device Sequence Number4868415
Product Code LZO
UDI-Device Identifier07630040720014
UDI-Public07630040720014
Combination Product (Y/N)N
Initial Reporter CountrySZ
PMA/510(K) Number
K173794
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/22/2021
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 Date09/30/2025
Device Catalogue Number01.18.402
Device Lot Number2007164
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/22/2021
Initial Report FDA Received Date07/22/2021
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;
Patient Age69 YR
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