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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED STD STEM SIZE 8; HIP STEM
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MEDACTA INTERNATIONAL SA STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED STD STEM SIZE 8; HIP STEM Back to Search Results
Catalog Number 01.18.438
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 07/15/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 july 2020: lot 1810265: (b)(4) items manufactured and released on 06-feb-2019.Expiration date: 2024-01-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
 
Event or Problem Description
The patient came in reporting pain due to a periprosthetic fracture; the cause of the periprosthetic fracture is unknown.The surgeon cabled the fracture and revised the stem, head, and liner 6 months after primary.The surgery was completed successfully.
 
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Brand Name
STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED STD STEM SIZE 8
Common Device Name
HIP STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874, CHE
SZ  6874, CHE
MDR Report Key10366566
Report Number3005180920-2020-00493
Device Sequence Number11349128
Product Code LZO
UDI-Device Identifier07630040720274
UDI-Public07630040720274
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 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 Date01/23/2024
Device Catalogue Number01.18.438
Device Lot Number1810265
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/15/2020
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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