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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/11 MM L
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MEDACTA INTERNATIONAL SA TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/11 MM L Back to Search Results
Catalog Number 02.12.0311FL
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 08/15/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 september 2018.Lot 180922: (b)(4) items manufactured and released on 13 march 2018.Expiration date: 2023-02-27.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
Revision surgery performed due to infection 9 days after primary.The surgeon washed out the knee and swapped the poly.The pathogen is unknown.
 
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Brand Name
TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/11 MM L
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key7876584
Report Number3005180920-2018-00682
Device Sequence Number16663236
Product Code JWH
UDI-Device Identifier07630030862564
UDI-Public07630030862564
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K140826
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 09/14/2018
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 Date02/27/2023
Device Catalogue Number02.12.0311FL
Device Lot Number180922
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/15/2018
Initial Report FDA Received Date09/14/2018
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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