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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 6/13 MM L; KNEE TIBIAL INSERT
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/13 MM L; KNEE TIBIAL INSERT Back to Search Results
Model Number 02.12.0613FL
Health Effect - Clinical Code Joint Laxity (4526)
Date of Event 10/04/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review was performed on 11 october 2021: lot 189023: (b)(4) items manufactured and released on 18-dic-2018.Expiration date: 2023-dic-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
 
Event or Problem Description
At 2 years and 3 months after the primary surgery the patient came in reporting instability and the cause of the instability is unknown.The surgeon revised the insert (from 13 mm to 17 mm) and the surgery was completed successfully.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/13 MM L
Common Device Name
KNEE TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key12743014
Report Number3005180920-2021-00842
Device Sequence Number17885440
Product Code JWH
UDI-Device Identifier07630030862694
UDI-Public07630030862694
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 Year2019
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) 11/03/2021
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 Date12/05/2023
Device Model Number02.12.0613FL
Device Catalogue Number02.12.0613FL
Device Lot Number189023
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/04/2021
Initial Report FDA Received Date11/03/2021
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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