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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 32 / E
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MEDACTA INTERNATIONAL SA LINER: CC E CC LIGHT FLAT PE HC LINER Ø 32 / E Back to Search Results
Model Number 01.26.3244HCT
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 01/16/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 january 2020.Lot 154195: (b)(4) items manufactured and released on 29-oct-2015.Expiration date: 2020-10-10.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 since 2016.
 
Event or Problem Description
Revision surgery performed due to infection.Only the inlay has been changed.
 
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Brand Name
LINER: CC E CC LIGHT FLAT PE HC LINER Ø 32 / E
Common Device Name
FLAT PE HC LINER
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key9710854
Report Number3005180920-2020-00060
Device Sequence Number11675081
Product Code LZO
UDI-Device Identifier07630030807572
UDI-Public07630030807572
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K103352
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 02/14/2020
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 Health Professional
Device Expiration Date10/10/2020
Device Model Number01.26.3244HCT
Device Catalogue Number01.26.3244HCT
Device Lot Number154195
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/16/2020
Initial Report FDA Received Date02/14/2020
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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