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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 5/11 MM R
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM R Back to Search Results
Model Number 02.12.0511FR
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 02/08/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19.02.2021: lot 1910205: (b)(4) items manufactured and released on 02-gen-2020.Expiration date: 2024-12-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
 
Event or Problem Description
The patient came in 6 months after the previous revision surgery due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the poly.The surgery was completed successfully.The previous revision surgery was performed due to infection (washout and liner revision performed).The patient had primary knee surgery on (b)(6) 2017.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM R
Common Device Name
TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key11420960
Report Number3005180920-2021-00178
Device Sequence Number14147299
Product Code JWH
UDI-Device Identifier07630030862663
UDI-Public07630030862663
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K140826
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 03/05/2021
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 Date12/09/2024
Device Model Number02.12.0511FR
Device Catalogue Number02.12.0511FR
Device Lot Number1910205
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/07/2021
Initial Report FDA Received Date03/05/2021
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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