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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 2/10 MM R
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R Back to Search Results
Model Number 02.12.0210FR
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 01/06/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07 january 2020.Lot 180423: (b)(4) items manufactured and released on 17-apr-2018.Expiration date: 2023-04-04.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
A year and a half after a successful primary total knee, the patient complaint on a anterior knee pain.The surgeon decided to resurface the patella and according to a little flexion laxity he also decided to remove the liner and to change it to 12mm height instead of 10mm that was inside.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R
Common Device Name
TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key9676087
Report Number3005180920-2020-00019
Device Sequence Number3414459
Product Code JWH
UDI-Device Identifier07630030826146
UDI-Public07630030826146
Combination Product (Y/N)N
Initial Reporter CountryIS
PMA/510(K) Number
K121416
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2020
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 02/06/2020
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 Date04/04/2023
Device Model Number02.12.0210FR
Device Catalogue Number02.12.0210FR
Device Lot Number180423
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/07/2020
Initial Report FDA Received Date02/06/2020
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;
Patient Age72 YR
Patient Weight75
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