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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 / F; ACETABULAR PE LINER
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MEDACTA INTERNATIONAL SA LINER: CC E CC LIGHT FLAT PE HC LINER 36 / F; ACETABULAR PE LINER Back to Search Results
Model Number 01.26.3648HCT
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 08/07/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 01.Sep.2020: lot 1910304: (b)(4) items manufactured and released on 22-jan-2020.Expiration date: 2025-01-05.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 since 2016.
 
Event or Problem Description
Revision surgery performed due to infection, 20 days after the previous revision surgery (previously liner and head were revised due to dislocation).The inlay was a medacta product.
 
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Brand Name
LINER: CC E CC LIGHT FLAT PE HC LINER 36 / F
Common Device Name
ACETABULAR PE LINER
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key10493017
Report Number3005180920-2020-00579
Device Sequence Number2687550
Product Code LZO
UDI-Device Identifier07630030807688
UDI-Public07630030807688
Combination Product (Y/N)N
Initial Reporter CountrySZ
PMA/510(K) Number
K103352
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 09/04/2020
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 Date01/05/2025
Device Model Number01.26.3648HCT
Device Catalogue Number01.26.3648HCT
Device Lot Number1910304
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/06/2020
Initial Report FDA Received Date09/04/2020
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;
Patient Age78 YR
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