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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 2/11 MM R
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 2/11 MM R Back to Search Results
Model Number 02.12.0211FR
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 09/29/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 october 2020.Lot 176167: (b)(4) manufactured and released on 11-jan-2018.Expiration date: 2022-12-14.No anomalies found related to the problem.To date, (b)(4) of the same lot have been already sold without any other similar reported event.
 
Event or Problem Description
The patient came in reporting instability and the cause of the instability is unknown.The surgeon revised the sphere insert flex right 11mm s2 with a sphere insert flex right 13mm s2 1 year and 3 months after primary.The surgery was completed successfully.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 2/11 MM R
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key10741057
Report Number3005180920-2020-00756
Device Sequence Number3335780
Product Code JWH
UDI-Device Identifier07630030862540
UDI-Public07630030862540
Combination Product (Y/N)Y
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K140826
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/27/2020
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 Date12/14/2022
Device Model Number02.12.0211FR
Device Catalogue Number02.12.0211FR
Device Lot Number176167
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/30/2020
Initial Report FDA Received Date10/27/2020
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;
Patient Age76 YR
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