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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 3/12 MM R
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM R Back to Search Results
Model Number 02.12.0312FR
Health Effect - Clinical Code Joint Laxity (4526)
Date of Event 01/26/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 february 2021.Lot 184900: (b)(4) items manufactured and released on 18-sep-2018.Expiration date: 2023-08-23.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
The patient came in reporting instability 4 months after the primary.The cause of the instability is unknown.The surgeon revised the tibial insert fixed sphere flex #3/12 mm r with a gmk-sphere tibial insert - flex s3r - 17mm.The surgery was completed successfully.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM R
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key11372362
Report Number3005180920-2021-00137
Device Sequence Number19842921
Product Code JWH
UDI-Device Identifier07630030826382
UDI-Public07630030826382
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 company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 02/24/2021
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 Date08/23/2023
Device Model Number02.12.0312FR
Device Catalogue Number02.12.0312FR
Device Lot Number184900
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/26/2021
Initial Report FDA Received Date02/24/2021
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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