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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 2/10 MM R
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R Back to Search Results
Model Number 02.12.0210FR
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 09/23/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 september 2020 lot 1810387: (b)(4) items manufactured and released on 11-mar-2019.Expiration date: 2024-02-27.No anomalies found related to the problem.To date, 74 items of the same lot have been already sold without any other similar reported event.
 
Event or Problem Description
The patient came in reporting instability due to loose ligaments.The cause of the loose ligaments is unknown.The surgeon revised the sphere insert flex right 10mm s2 to a gmk-sphere tibial insert - flex s4l - 17mm 1 year and 1 month after surgery.The surgery was completed successfully.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key10697598
Report Number3005180920-2020-00726
Device Sequence Number3845122
Product Code JDI
UDI-Device Identifier07630030826146
UDI-Public07630030826146
Combination Product (Y/N)Y
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K121416
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
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) 10/19/2020
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 Date02/27/2024
Device Model Number02.12.0210FR
Device Catalogue Number02.12.0210FR
Device Lot Number1810387
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/23/2020
Initial Report FDA Received Date10/19/2020
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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