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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 4/12 MM R
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R Back to Search Results
Model Number 02.12.0412FR
Health Effect - Clinical Code Joint Laxity (4526)
Date of Event 12/15/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 january 2021.Lot 135743: (b)(4) items manufactured and released on 19-feb-2014.Expiration date: 2019-01.No anomalies found related to the problem to date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2016.
 
Event or Problem Description
The patient came in reporting instability due to laxity, 2 years 11 months after the primary.The surgeon revised the 12mm poly with a 17mm poly and the surgery was completed successfully.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key11168792
Report Number3005180920-2021-00038
Device Sequence Number11694036
Product Code JWH
UDI-Device Identifier07630030826580
UDI-Public07630030826580
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)Unknown
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 01/14/2021
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 Date01/31/2019
Device Model Number02.12.0412FR
Device Catalogue Number02.12.0412FR
Device Lot Number135743
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/15/2020
Initial Report FDA Received Date01/14/2021
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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