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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 CR SIZE 4/11 MM L; KNEE TIBIAL INSERT
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 4/11 MM L; KNEE TIBIAL INSERT Back to Search Results
Model Number 02.12.0411CRL
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 09/07/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 september 2021: lot 2002126: (b)(4) items manufactured and released on 24-03-2020.Expiration date: 2025-03-11.No anomalies found related to the problem.To date,(b)(4) items of this same lot have been sold without other similar reported events.
 
Event or Problem Description
Revision surgery was performed 1,5 months after the primary surgery due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the poly and the surgery was completed successfully.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 4/11 MM L
Common Device Name
KNEE TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key12567103
Report Number3005180920-2021-00790
Device Sequence Number3488235
Product Code JWH
UDI-Device Identifier07630040707497
UDI-Public07630040707497
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K181635
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/04/2021
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 Date03/11/2025
Device Model Number02.12.0411CRL
Device Catalogue Number02.12.0411CRL
Device Lot Number2002126
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/07/2021
Initial Report FDA Received Date10/04/2021
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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