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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 2/11 MM L
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/11 MM L Back to Search Results
Model Number 02.12.0211FL
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 06/21/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 june 2021: lot 157438: (b)(4) items manufactured and released on 20-apr-2016.Expiration date: 2021-04-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with a similar reported event.
 
Event or Problem Description
4 years 7 months after the primary the patient came in for a post-op appointment and it was observed that a screw from the tibial insert had loosened.The surgeon revised the poly and the surgery was completed successfully.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/11 MM L
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key12149874
Report Number3005180920-2021-00578
Device Sequence Number4616377
Product Code JWH
UDI-Device Identifier07630030862526
UDI-Public07630030862526
Combination Product (Y/N)N
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)Unknown
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/12/2021
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? Yes
Operator of Device Health Professional
Device Expiration Date04/05/2021
Device Model Number02.12.0211FL
Device Catalogue Number02.12.0211FL
Device Lot Number157438
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/21/2021
Initial Report FDA Received Date07/12/2021
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 Other; Required Intervention;
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