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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 5 / 10 MM; TIBIAL KNEE INSERT
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MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 5 / 10 MM; TIBIAL KNEE INSERT Back to Search Results
Model Number 02.07.0510FUC
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 02/15/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 february 2021: lot 121455: (b)(4) items manufactured and released on 04-sept-2012.Expiration date: 2017-07-31.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
The patient came in due to signs of an infection and the pathogen is unknown.8 years 1 month after primary the surgeon performed a washout and revised the poly and the surgery was completed successfully.
 
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Brand Name
GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 5 / 10 MM
Common Device Name
TIBIAL KNEE INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key11482001
Report Number3005180920-2021-00202
Device Sequence Number3876952
Product Code JWH
UDI-Device Identifier07630030818196
UDI-Public07630030818196
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K090988
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 03/15/2021
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 Date07/31/2017
Device Model Number02.07.0510FUC
Device Catalogue Number02.07.0510FUC
Device Lot Number121455
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/15/2021
Initial Report FDA Received Date03/15/2021
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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