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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM COLLARED STEM COLLARED HA COATED STD STEM SIZE 4; HIP CEMENTLESS COLLARED STEM
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MEDACTA INTERNATIONAL SA STEM: AMISTEM COLLARED STEM COLLARED HA COATED STD STEM SIZE 4; HIP CEMENTLESS COLLARED STEM Back to Search Results
Catalog Number 01.18.234
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 05/20/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 june 2019: lot 180042: (b)(4) items manufactured and released on 13 june 2018.Expiration date: 2023-05-27.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
Revision surgery after 2 months from the primary due to pain caused by a loose stem.The surgeon revised the stem, liner and head and the surgery was completed successfully.
 
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Brand Name
STEM: AMISTEM COLLARED STEM COLLARED HA COATED STD STEM SIZE 4
Common Device Name
HIP CEMENTLESS COLLARED STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key8707238
Report Number3005180920-2019-00483
Device Sequence Number1992333
Product Code LZO
UDI-Device Identifier07630030804595
UDI-Public07630030804595
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K121011
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 06/18/2019
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 Date05/27/2023
Device Catalogue Number01.18.234
Device Lot Number180042
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/21/2019
Initial Report FDA Received Date06/18/2019
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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