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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA TIBIAL INSERT FIXED SPHERE FLEX SIZE2/13 MM R
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MEDACTA INTERNATIONAL SA TIBIAL INSERT FIXED SPHERE FLEX SIZE2/13 MM R Back to Search Results
Catalog Number 02.12.0211FR
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 01/02/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2018.Lot 146632: thirty items manufactured and released on (b)(6) 2015.Expiration date: (b)(6) 2020.No anomalies found related to the problem.To date, 20 items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
The patient came in due to signs of infection.The pathogen is unknown.The surgeon washed out the knee and swapped the insert.The surgery was completed successfully.
 
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Brand Name
TIBIAL INSERT FIXED SPHERE FLEX SIZE2/13 MM R
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key7233959
Report Number3005180920-2018-00008
Device Sequence Number1476160
Product Code JWH
UDI-Device Identifier07630030862540
UDI-Public07630030862540
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K140826
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2018
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 02/01/2018
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 Date03/31/2020
Device Catalogue Number02.12.0211FR
Device Lot Number146632
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/02/2018
Initial Report FDA Received Date02/01/2018
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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