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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S5 LM; TIBIAL TRAY CEMENTED
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MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S5 LM; TIBIAL TRAY CEMENTED Back to Search Results
Model Number 02.18.TF5.LM
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 01/18/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 february 2021: lot 1900847: (b)(4) items manufactured and released on 05-july-2019.Expiration date: 2024-06-23.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 after 1 years and 2 months from the primary surgery reporting pain due to a loose tibial component.The cause of the loose tibial component is unknown.The surgeon revised the tibial tray and insert.The surgery was completed successfully.
 
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Brand Name
MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S5 LM
Common Device Name
TIBIAL TRAY CEMENTED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key11331834
Report Number3005180920-2021-00119
Device Sequence Number19038384
Product Code HSX
UDI-Device Identifier07630030896774
UDI-Public07630030896774
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 Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 02/16/2021
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 Date06/23/2024
Device Model Number02.18.TF5.LM
Device Catalogue Number02.18.TF5.LM
Device Lot Number1900847
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/18/2021
Initial Report FDA Received Date02/16/2021
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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