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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: CC E CC LIGHT FLAT PE HC LINER Ø 36 / E
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MEDACTA INTERNATIONAL SA LINER: CC E CC LIGHT FLAT PE HC LINER Ø 36 / E Back to Search Results
Catalog Number 01.26.3644HCT
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 10/09/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 october 2019.Lot 1810757: (b)(4) items manufactured and released on 04-mar-2019.Expiration date: 2024-02-25.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
Revision following an infection.Medacta liner and competitor's head have been revised.The surgery was completed successfully.Previous surgery details are unknown.
 
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Brand Name
LINER: CC E CC LIGHT FLAT PE HC LINER Ø 36 / E
Common Device Name
FLAT PE HC LINER
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key9289625
Report Number3005180920-2019-00936
Device Sequence Number13960822
Product Code LZO
UDI-Device Identifier07630030807671
UDI-Public07630030807671
Combination Product (Y/N)N
Initial Reporter CountryIT
PMA/510(K) Number
K103352
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 11/07/2019
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 Date02/25/2024
Device Catalogue Number01.26.3644HCT
Device Lot Number1810757
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/08/2019
Initial Report FDA Received Date11/07/2019
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;
Patient Age84 YR
Patient Weight85
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