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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 RM - 8MM
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MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL INSERT FIX S6 RM - 8MM Back to Search Results
Model Number 02.18.IF6.08.RM
Health Effect - Clinical Code Hematoma (1884)
Date of Event 01/07/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 january 2020: lot 167829: (b)(4) items manufactured and released on 14-dec-2016.Expiration date: 2021-11-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
 
Event or Problem Description
The patient came in reporting pain due to a hematoma in the knee.The cause of the hematoma is unknown.The surgeon performed an washout and poly-swap almost 3 weeks after primary.The surgery was completed successfully.
 
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Brand Name
MOTO PARTIAL KNEE TIBIAL INSERT FIX S6 RM - 8MM
Common Device Name
KNEE TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key9664310
Report Number3005180920-2020-00022
Device Sequence Number3135309
Product Code HSX
UDI-Device Identifier07630030896347
UDI-Public07630030896347
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 Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 02/04/2020
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 Date11/29/2021
Device Model Number02.18.IF6.08.RM
Device Catalogue Number02.18.IF6.08.RM
Device Lot Number167829
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/07/2020
Initial Report FDA Received Date02/04/2020
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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