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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 5/13
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/13 Back to Search Results
Catalog Number 02.12.0513FL
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 09/30/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 october 2019.Lot 155787: 25 items manufactured and released on 18-feb-2016.Expiration date: 2021-02-01.No anomalies found related to the problem.To date, 16 items of the same lot have been already sold without any other similar reported event.
 
Event or Problem Description
The patient came in complaining of instability due to laxity 2 years after primary.The surgeon revised the medacta sphere insert flex left 13mm s5 with a medacta sphere insert flex left 17mm s5.The surgery was completed successfully.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/13
Common Device Name
TIBIAL INSERT FIXED FLEX
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key9254512
Report Number3005180920-2019-00907
Device Sequence Number14090614
Product Code JWH
UDI-Device Identifier07630030862656
UDI-Public07630030862656
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K140826
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2019
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/30/2019
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 Date02/01/2021
Device Catalogue Number02.12.0513FL
Device Lot Number155787
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/30/2019
Initial Report FDA Received Date10/30/2019
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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