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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
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MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S5 LM Back to Search Results
Model Number 02.18.TF5.LM
Medical Device Problem Code Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code Pain (1994)
Date of Event 05/11/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 may 2021: lot 1902961: (b)(4) items manufactured and released on 27-aug-2019.Expiration date: 2024-07-28.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 loose tibial component.The cause of the loose tibial component is unknown.The surgeon revised the tibial tray and insert 6 months after primary.The surgery was completed successfully.
 
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Brand Name
MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S5 LM
Common Device Name
KNEE TIBIAL TRAY FIX CEMENTED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key11973855
Report Number3005180920-2021-00479
Device Sequence Number19097427
Product Code HSX
UDI-Device Identifier07630030896774
UDI-Public07630030896774
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K162084
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 06/10/2021
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 Date07/28/2024
Device Model Number02.18.TF5.LM
Device Catalogue Number02.18.TF5.LM
Device Lot Number1902961
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/11/2021
Initial Report FDA Received Date06/10/2021
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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