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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 2/14 MM R
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/14 MM R Back to Search Results
Catalog Number 02.12.0214FR
Health Effect - Clinical Code Pain (1994)
Date of Event 03/06/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2018.Lot 167728: 30 items manufactured and released on 28 november 2012.Expiration date: (b)(6) 2017.No anomalies found related to the problem.To date, 18 items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
On (b)(6) 2018 the sales representative was informed by the surgeon that the patient came in complaining of pain.The surgeon plans to swap the poly.The date of the revision is unknown at this time.More information to follow the case.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/14 MM R
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key7398589
Report Number3005180920-2018-00205
Device Sequence Number1740906
Product Code LPH
UDI-Device Identifier07630030812156
UDI-Public07630030812156
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K103721
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 06/14/2018
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 Date10/31/2017
Device Catalogue Number02.12.0214FR
Device Lot Number123212
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 04/05/2018
Supplement Date Received by Manufacturer04/05/2018
Initial Report FDA Received Date04/05/2018
Supplement Report FDA Received Date06/14/2018
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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