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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 S3 RM
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MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE - TIBIAL TRAY FIX CEMENTED S3 RM Back to Search Results
Catalog Number 02.18.TF3.RM
Health Effect - Clinical Codes Bone Fracture(s) (1870); Pain (1994)
Date of Event 08/28/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 september 2017.Lot 160687: (b)(4) items manufactured and released on 24 october 2016.Expiration date: 2021-05-26.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 complaining of pain.The patient also had a fatigue fracture of the tibial bone.The surgeon revised all medacta hardware.The surgery was completed successfully.
 
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Brand Name
MOTO PARTIAL KNEE - TIBIAL TRAY FIX CEMENTED S3 RM
Common Device Name
TIBIAL TRAY FIX CEMENTED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key6903984
Report Number3005180920-2017-00538
Device Sequence Number1041381
Product Code HSX
UDI-Device Identifier07630030896743
UDI-Public07630030896743
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 Year2017
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/29/2017
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 Date05/26/2021
Device Catalogue Number02.18.TF3.RM
Device Lot Number160687
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/30/2017
Initial Report FDA Received Date09/29/2017
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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