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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/13 MM L
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/13 MM L Back to Search Results
Model Number 02.12.0513FL
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 11/10/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 november 2020: lot 156315: (b)(4) items manufactured and released on 24-mar-2016.Expiration date: 2021-03-13.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 since 2016.
 
Event or Problem Description
The patient came in after 2 years and 7 months from the primary surgery reporting instability and the cause of the instability is unknown.The surgeon revised the sphere insert flex left 13mm s5 with a thicker competitor poly to give the patient more stability.The surgery was completed successfully.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/13 MM L
Common Device Name
TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key10959336
Report Number3005180920-2020-00880
Device Sequence Number2419927
Product Code JWH
UDI-Device Identifier07630030862656
UDI-Public07630030862656
Combination Product (Y/N)Y
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K140826
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 12/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date03/13/2021
Device Model Number02.12.0513FL
Device Catalogue Number02.12.0513FL
Device Lot Number156315
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/10/2020
Initial Report FDA Received Date12/07/2020
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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