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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 LEFT
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 2/11 MM LEFT Back to Search Results
Catalog Number 02.12.0211FL
Medical Device Problem Code Device Issue (2379)
Health Effect - Clinical Code Pain (1994)
Date of Event 08/07/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Additional information received on (b)(6) 2017 and includes: the screw was not implanted during revision surgery.Batch review performed on (b)(6) 2017.Lot 157438: (b)(4) items manufactured and released on 20 april 2016.Expiration date: 2021-04-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
The patient came in complaining of pain.The screw backed out of the poly.The surgeon swapped the poly.The surgery was completed successfully.X-rays and explants are not available.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 2/11 MM LEFT
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key6844611
Report Number3005180920-2017-00488
Device Sequence Number68887
Product Code JWH
UDI-Device Identifier07630030862526
UDI-Public07630030862526
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K140826
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2017
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/06/2017
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? Yes
Operator of Device Health Professional
Device Expiration Date04/05/2021
Device Catalogue Number02.12.0211FL
Device Lot Number157438
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/07/2017
Initial Report FDA Received Date09/06/2017
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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