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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 S6 LM - 9MM
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MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL INSERT FIX S6 LM - 9MM Back to Search Results
Model Number 02.18.IF6.09.LM
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 04/13/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21 april 2020: lot 168025: (b)(4) items manufactured and released on 2-feb-2017.Expiration date: 2022-01-04.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
The patient came in, 1 year and 2 months after primary surgery, due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and liner-swap and the surgery was completed successfully.
 
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Brand Name
MOTO PARTIAL KNEE TIBIAL INSERT FIX S6 LM - 9MM
Common Device Name
KNEE TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key10046038
Report Number3005180920-2020-00278
Device Sequence Number3293354
Product Code HSX
UDI-Device Identifier07630030896354
UDI-Public07630030896354
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K162084
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 05/12/2020
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 Date01/04/2022
Device Model Number02.18.IF6.09.LM
Device Catalogue Number02.18.IF6.09.LM
Device Lot Number168025
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/13/2020
Initial Report FDA Received Date05/12/2020
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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