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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 36 / E; ACETABULAR PE HC LINER
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MEDACTA INTERNATIONAL SA LINER: CC E CC LIGHT FLAT PE HC LINER 36 / E; ACETABULAR PE HC LINER Back to Search Results
Model Number 01.26.3644HCT
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 10/01/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 october 2020: lot 133466: (b)(4) items manufactured and released on 25-sep-2013.Expiration date: 2018-08-31.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
The patient came in, 6 years and 11 months after primary surgery, due to signs of infection and the pathogen is unknown.The surgeon performed a washout and poly-swap and the surgery was completed successfully.
 
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Brand Name
LINER: CC E CC LIGHT FLAT PE HC LINER 36 / E
Common Device Name
ACETABULAR PE HC LINER
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key10738979
Report Number3005180920-2020-00763
Device Sequence Number3335778
Product Code LZO
UDI-Device Identifier07630030807671
UDI-Public07630030807671
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K103352
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2020
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/27/2020
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 Date08/31/2018
Device Model Number01.26.3644HCT
Device Catalogue Number01.26.3644HCT
Device Lot Number133466
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/01/2020
Initial Report FDA Received Date10/27/2020
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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