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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 4/11 MM R; KNEE TIBIAL INSERT
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM R; KNEE TIBIAL INSERT Back to Search Results
Catalog Number 02.12.0411FR
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 10/28/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 november 2019.Lot 1810395 : 175 items manufactured and released on 20-mar-2019.Expiration date: 2024-03-04.No anomalies found related to the problem.To date, 48 items of the same lot have been already sold without any other similar reported event.
 
Event or Problem Description
Revision surgery performed 2 months after the primary due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the insert successfully.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM R
Common Device Name
KNEE TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key9368476
Report Number3005180920-2019-00987
Device Sequence Number11440300
Product Code JWH
UDI-Device Identifier07630030862625
UDI-Public07630030862625
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 Year2019
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 11/25/2019
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 Date03/04/2024
Device Catalogue Number02.12.0411FR
Device Lot Number1810395
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/28/2019
Initial Report FDA Received Date11/25/2019
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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