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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 3/12 MM R
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM R Back to Search Results
Model Number 02.12.0312FR
Health Effect - Clinical Code Muscle/Tendon Damage (4532)
Date of Event 11/18/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 december 2020: lot 1910707: (b)(4) items manufactured and released on 5-feb-2020.Expiration date: 2025-01-21.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
The patient came in, 2 months after primary surgery, reporting pain due to a quad tendon rupture.The cause of the quad tendon rupture is unknown.The surgeon performed a quad tendon repair and revised the gmk-sphere tibial insert - flex s3r - 12mm with a gmk-sphere tibial insert - flex s3r - 12mn.The surgery was completed successfully.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM R
Common Device Name
TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key11036667
Report Number3005180920-2020-00932
Device Sequence Number1307521
Product Code JWH
UDI-Device Identifier07630030826382
UDI-Public07630030826382
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K121416
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
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) 12/18/2020
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 Date01/21/2025
Device Model Number02.12.0312FR
Device Catalogue Number02.12.0312FR
Device Lot Number1910707
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/24/2020
Initial Report FDA Received Date12/18/2020
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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