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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL INSERT FIX S3 RM - 8MM; TIBIAL INSERT FIXED
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MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL INSERT FIX S3 RM - 8MM; TIBIAL INSERT FIXED Back to Search Results
Model Number 02.18.IF3.08.RM
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 06/15/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24.06.2021: lot 2008215: (b)(4) items manufactured and released on 30-09-2020.Expiration date: 2025-09-15.No anomalies found related to the problem.To date, (b)(4) items of this same lot have been sold without other similar reported events.
 
Event or Problem Description
1 month after the primary surgery the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the poly and the surgery was completed successfully.
 
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Brand Name
MOTO PARTIAL KNEE TIBIAL INSERT FIX S3 RM - 8MM
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key12133638
Report Number3005180920-2021-00564
Device Sequence Number3704697
Product Code HSX
UDI-Device Identifier07630030895982
UDI-Public07630030895982
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K162084
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/08/2021
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 Date09/15/2025
Device Model Number02.18.IF3.08.RM
Device Catalogue Number02.18.IF3.08.RM
Device Lot Number2008215
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/15/2021
Initial Report FDA Received Date07/08/2021
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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