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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L; KNEE TIBIAL INSERT
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L; KNEE TIBIAL INSERT Back to Search Results
Model Number 02.12.0414FL
Health Effect - Clinical Code Joint Laxity (4526)
Date of Event 09/14/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21 september 2021: lot 1903256: (b)(4) items manufactured and released on 21-jun-2019.Expiration date: 2024-06-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
 
Event or Problem Description
1 year and 1 month after the primary surgery the patient came in reporting instability and the cause of the instability is unknown.The surgeon revised the gmk-sphere tibial insert - flex s4l - 14 mm with a gmk-sphere tibial insert - flex s4l - 20mm.The surgery was completed successfully.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L
Common Device Name
KNEE TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key12603765
Report Number3005180920-2021-00799
Device Sequence Number3473250
Product Code JWH
UDI-Device Identifier07630030826610
UDI-Public07630030826610
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K121416
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 company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/11/2021
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 Date06/04/2024
Device Model Number02.12.0414FL
Device Catalogue Number02.12.0414FL
Device Lot Number1903256
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/14/2021
Initial Report FDA Received Date10/11/2021
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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