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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 04/21/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 may 2018; lot 175238: (b)(4) items manufactured and released on 30 november 2017.Expiration date: 2022-11-15; 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
About 2 month after primary the patient was revised for a knee infection.Liner swap.The surgery was completed successfully.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 Key7525817
Report Number3005180920-2018-00348
Device Sequence Number1333540
Product Code JWH
UDI-Device Identifier07630030862564
UDI-Public07630030862564
Combination Product (Y/N)N
Initial Reporter StateIL
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 Other
Type of Report Initial
Report Date (Section B) 05/18/2018
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 Date11/15/2022
Device Catalogue Number02.12.0311FL
Device Lot Number175238
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 04/21/2018
Initial Report FDA Received Date05/18/2018
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;
Patient Age77 YR
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