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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T4-I3 R; KNEE TIBIAL TRAY
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T4-I3 R; KNEE TIBIAL TRAY Back to Search Results
Catalog Number 02.12.T4I3R
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 02/13/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Batch review performed on 13 march 2019: lot 180380: (b)(4) items manufactured and released on 17-may-2018.Expiration date: 2023-05-06.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
One of the surgeon tech made a mistake in a surgery by giving the surgeon a tibial component t4-i3 for femoral component 4.The patient has been informed to have a tibial component t4-i3, insert 3 and femoral component 4.The surgeon will follow the progression of this patient.
 
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Brand Name
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T4-I3 R
Common Device Name
KNEE TIBIAL TRAY
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key8416474
Report Number3005180920-2019-00154
Device Sequence Number2051361
Product Code JWH
UDI-Device Identifier07630030827167
UDI-Public07630030827167
Combination Product (Y/N)N
Initial Reporter CountryPM
PMA/510(K) Number
K121416
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 03/13/2019
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 Date05/06/2023
Device Catalogue Number02.12.T4I3R
Device Lot Number180380
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/14/2019
Initial Report FDA Received Date03/13/2019
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 Other;
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