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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 S6 LM

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MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S6 LM Back to Search Results
Model Number 02.18.TF6.LM
Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)
Patient Problem Joint Disorder (2373)
Event Date 03/19/2019
Event Type  Injury  
Manufacturer Narrative

Batch review performed on 15 april 2020: lot 182129: (b)(4) items manufactured and released on 18-jul-2018. Expiration date: 2023-06-19. 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. Clinical evaluation performed by medacta medical affairs director: less than 1 year after uka, the tibial component gets loose and the joint requires revision, probably to tka. Only one radiographic image is supplied, from which the tibial component looks in suboptimal position - we have no history, hence we do not know if this position was chosen at the time of index surgery or if it is the result of migration. The lateral view and the postoperative images could have helped to better understand. We have no reason to suspect a faulty device.

 
Event Description

The patient came in reporting pain due to a loose tibial tray and the cause is unknown. The surgeon removed the femoral component, tibial tray, and insert 10 months and a half after primary. The surgery was completed successfully.

 
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Brand NameMOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S6 LM
Type of DeviceKNEE TIBIAL TRAY
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ 6874
Manufacturer (Section G)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ 6874
Manufacturer Contact
stefano baj
strada regina
castel san pietro, switzerland 6874
SZ   6874
MDR Report Key9961388
MDR Text Key192065631
Report Number3005180920-2020-00246
Device Sequence Number1
Product Code HSX
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK162084
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 04/15/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/15/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number02.18.TF6.LM
Device Catalogue Number02.18.TF6.LM
Device LOT Number182129
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/19/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured07/18/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/15/2020 Patient Sequence Number: 1
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