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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 3/13 MM
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/13 MM Back to Search Results
Model Number 02.12.0311FR
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 05/15/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 may 2020: lot 1906096: (b)(4) items manufactured and released on 31-jul-2019.Expiration date: 2024-07-15.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, 1.5 months after primary surgery, due to signs of an infection.The surgeon performed an i&d and revised the sphere insert flex right 11mm s3 with a sphere insert flex right 11mm s3.The surgery was completed successfully.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/13 MM
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
CH  6874
MDR Report Key10069394
Report Number3005180920-2020-00289
Device Sequence Number19771376
Product Code JWH
UDI-Device Identifier07630030862588
UDI-Public07630030862588
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K140826
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 05/19/2020
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 Date07/15/2024
Device Model Number02.12.0311FR
Device Catalogue Number02.12.0311FR
Device Lot Number1906096
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/24/2020
Initial Report FDA Received Date05/19/2020
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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