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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 S7 RM - 8MM
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MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL INSERT FIX S7 RM - 8MM Back to Search Results
Catalog Number 02.18.IF7.08.RM
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 11/27/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 december 2018.Lot 161262: (b)(4) items manufactured and released on 12 october 2016.Expiration date: 2021-06-12.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 due to signs of infection, 14 days after primary surgery, and the pathogen is unknown.The surgeon performed an i&d and poly swap and the surgery was completed successfully.
 
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Brand Name
MOTO PARTIAL KNEE TIBIAL INSERT FIX S7 RM - 8MM
Common Device Name
KNEE TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key8188875
Report Number3005180920-2018-01029
Device Sequence Number11329311
Product Code HSX
UDI-Device Identifier07630030896460
UDI-Public07630030896460
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K162084
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) 12/21/2018
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 Date06/12/2021
Device Catalogue Number02.18.IF7.08.RM
Device Lot Number161262
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/27/2018
Initial Report FDA Received Date12/21/2018
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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