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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 6/20 MM L
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MEDACTA INTERNATIONAL SA TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/20 MM L Back to Search Results
Catalog Number 02.12.0620FL
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 01/06/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 february 2018 lot 144621: (b)(4) items manufactured and released on 23 september 2014.Expiration date: 2019-08-31 no anomalies found related to the problem.To date, (b)(4) item 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 surgeon washed out the knee and swapped the poly.The surgery was completed successfully.
 
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Brand Name
TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/20 MM L
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key7240627
Report Number3005180920-2018-00021
Device Sequence Number11068450
Product Code JWH
UDI-Device Identifier07630030827099
UDI-Public07630030827099
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K121416
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 02/05/2018
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 Date08/31/2019
Device Catalogue Number02.12.0620FL
Device Lot Number144621
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 01/06/2018
Initial Report FDA Received Date02/05/2018
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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