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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/11 MM R
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/11 MM R Back to Search Results
Model Number 02.12.0511FR
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 04/19/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 april 2021: lot 146652: 24 items manufactured and released on 07-apr-2015.Expiration date: 2020-02-29.No anomalies found related to the problem.To date, 23 items of the same lot have been already sold without any similar reported event since 1-1-2017.
 
Event or Problem Description
5 years and 2 months after primary the liner fixation screw had loosened.The cause of the screw loosening is unknown.The surgeon removed the screw and did not revise any implants.The surgery was completed successfully.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/11 MM R
Common Device Name
TIBIAL INSERT FIXED FLEX
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key11847279
Report Number3005180920-2021-00385
Device Sequence Number14383666
Product Code JWH
UDI-Device Identifier07630030862663
UDI-Public07630030862663
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K140826
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 05/19/2021
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 Date02/29/2020
Device Model Number02.12.0511FR
Device Catalogue Number02.12.0511FR
Device Lot Number146652
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/19/2021
Initial Report FDA Received Date05/19/2021
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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