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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT FLAT PE HC LINER Ø40/G; FLAT LINER
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MEDACTA INTERNATIONAL SA LINER: MPACT FLAT PE HC LINER Ø40/G; FLAT LINER Back to Search Results
Catalog Number 01.32.4052HCT
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 03/10/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 april 2018; lot 168477: (b)(4) items manufactured and released on 23 february 2017.Expiration date: 2022-02-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
The patient came in due to signs of infection.The surgeon washed out the hip and revised the liner.The surgery was completed successfully.
 
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Brand Name
LINER: MPACT FLAT PE HC LINER Ø40/G
Common Device Name
FLAT LINER
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key7412264
Report Number3005180920-2018-00215
Device Sequence Number16452907
Product Code LZO
UDI-Device Identifier07630030812286
UDI-Public07630030812286
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K122641
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/10/2018
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 Date02/09/2022
Device Catalogue Number01.32.4052HCT
Device Lot Number168477
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/12/2018
Initial Report FDA Received Date04/10/2018
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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