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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 6/12 MM R
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/12 MM R Back to Search Results
Model Number 02.12.0612FR
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 04/15/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27.04.2021: lot 179711: (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 without any other similar reported event.Additional items involved in the event: gmk-sphere 02.12.0007r femoral component sphere cemented size 7 r (k121416) lot.186126 batch review performed on 27.Apr.2021.Lot 186126: (b)(4) items manufactured and released on 27-sep-2018.Expiration date: 2023-09-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Gmk-sphere 02.07.1206r tibial tray fixed cemented size 6 r (k090988) lot.180251 batch review performed on 27.Apr.2021.Lot 180251: (b)(4) items manufactured and released on 17-may-2018.Expiration date: 2023-05-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
 
Event or Problem Description
2 years and 4 months after the primary surgery the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout, removed all components and implanted an antibiotic spacer.The surgery was completed successfully.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/12 MM R
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key11795930
Report Number3005180920-2021-00378
Device Sequence Number19837922
Product Code JWH
UDI-Device Identifier07630030826986
UDI-Public07630030826986
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 Year2018
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) 05/10/2021
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 Number02.12.0612FR
Device Catalogue Number02.12.0612FR
Device Lot Number179711
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/15/2021
Initial Report FDA Received Date05/10/2021
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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