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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 3/14 MM L
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MEDACTA INTERNATIONAL SA TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/14 MM L Back to Search Results
Catalog Number 02.12.0314FL
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 06/11/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 july 2018; lot 157440: (b)(4) items manufactured and released on 21 april 2016.Expiration date: 2021-04-06; 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 due to signs of infection.The pathogen is unknown.The surgeon washed out the knee and swapped the poly.
 
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Brand Name
TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/14 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 Key7677480
Report Number3005180920-2018-00498
Device Sequence Number10974811
Product Code JWH
UDI-Device Identifier07630030826412
UDI-Public07630030826412
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K121416
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/11/2018
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 Date04/06/2021
Device Catalogue Number02.12.0314FL
Device Lot Number157440
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/12/2018
Initial Report FDA Received Date07/11/2018
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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