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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
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MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL INSERT FIX S3 RM - 8MM Back to Search Results
Catalog Number 02.18.IF3.08.RM
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 05/29/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 june 2019: lot 161226: (b)(4) items manufactured and released on 24-oct-2016.Expiration date: 2021-06-01.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 years after primary the surgeon revised the patient for a infection.The surgeon performed an i&d and liner swap and the surgery was completed successfully.The pathogen is unknown.
 
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Brand Name
MOTO PARTIAL KNEE TIBIAL INSERT FIX S3 RM - 8MM
Common Device Name
KNEE TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key8731007
Report Number3005180920-2019-00517
Device Sequence Number2004418
Product Code HSX
UDI-Device Identifier07630030895982
UDI-Public07630030895982
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K162084
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 06/25/2019
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 Date06/01/2021
Device Catalogue Number02.18.IF3.08.RM
Device Lot Number161226
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/29/2019
Initial Report FDA Received Date06/25/2019
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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