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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 5/12 MM L
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM L Back to Search Results
Model Number 02.12.0512FL
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 02/05/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 february 2021: lot 180400: (b)(4) items manufactured and released on 19-apr-2018.Expiration date: 2023-04-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event.
 
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the poly 1 month and 1 week after primary.The surgery was completed successfully.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM L
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key11451745
Report Number3005180920-2021-00183
Device Sequence Number4049089
Product Code JWH
UDI-Device Identifier07630030826771
UDI-Public07630030826771
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 Year2021
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) 03/10/2021
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 Date04/05/2023
Device Model Number02.12.0512FL
Device Catalogue Number02.12.0512FL
Device Lot Number180400
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/08/2021
Initial Report FDA Received Date03/10/2021
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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