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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 4/12 MM R; KNEE TIBIAL INSERT FLEX
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/12 MM R; KNEE TIBIAL INSERT FLEX Back to Search Results
Catalog Number 02.12.0412FR
Health Effect - Clinical Code Limited Mobility Of The Implanted Joint (2671)
Date of Event 06/03/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 3 july 2019: lot 172821: (b)(4) items manufactured and released on 13-jul-2017.Expiration date: 2022-06-23.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
Revision surgery performed after 1 year and 9 months after the primary due to knee stiffness.The surgeon revised the 12mm poly with a 10 mm poly and the surgery was completed successfully.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/12 MM R
Common Device Name
KNEE TIBIAL INSERT FLEX
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key8757900
Report Number3005180920-2019-00528
Device Sequence Number2565661
Product Code JWH
UDI-Device Identifier07630030826580
UDI-Public07630030826580
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K121416
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Operator of Device Health Professional
Device Expiration Date06/23/2022
Device Catalogue Number02.12.0412FR
Device Lot Number172821
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/03/2019
Initial Report FDA Received Date07/03/2019
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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