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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 5/13 MM R; KNEE TIBIAL INSERT
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/13 MM R; KNEE TIBIAL INSERT Back to Search Results
Model Number 02.12.0513FR
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 01/26/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07.Feb.2020: lot 177446: (b)(4) items manufactured and released on 01-mar-2018.Expiration date: 2023-02-12.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
Revision surgery needed after 10 months from the primary due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the insert.The surgery was completed successfully.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/13 MM R
Common Device Name
KNEE TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key9744764
Report Number3005180920-2020-00088
Device Sequence Number2456146
Product Code JWH
UDI-Device Identifier07630030862670
UDI-Public07630030862670
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K140826
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 02/24/2020
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 Date02/12/2023
Device Model Number02.12.0513FR
Device Catalogue Number02.12.0513FR
Device Lot Number177446
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/27/2020
Initial Report FDA Received Date02/24/2020
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 Age64 YR
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