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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 5/14 MM L
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/14 MM L Back to Search Results
Model Number 02.12.0514FL
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 12/23/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 january 2021: lot 147260: (b)(4) items manufactured and released on 14-jan-2015.Expiration date: 2019-11-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold.No other similar events have been reported since 2017.
 
Event or Problem Description
Revision surgery due to instability, 2 years after the primary.The cause of instability is unknown.The surgeon revised the 14 mm insert with 17 mm insert and the surgery was completed successfully.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/14 MM L
Common Device Name
TIBIAL INSERT FIXED FLEX
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key11214861
Report Number3005180920-2021-00062
Device Sequence Number14479233
Product Code JWH
UDI-Device Identifier07630030826818
UDI-Public07630030826818
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K121416
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2020
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 01/22/2021
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 Date11/30/2019
Device Model Number02.12.0514FL
Device Catalogue Number02.12.0514FL
Device Lot Number147260
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/23/2020
Initial Report FDA Received Date01/22/2021
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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