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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/20MM; KNEE TIBIAL INSERT
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MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/20MM; KNEE TIBIAL INSERT Back to Search Results
Model Number 02.07.0420SCF
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 03/16/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 march 2021: lot 1906430: (b)(4) items manufactured and released on 3-sep-2019.Expiration date: 2024-08-19.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
5 months after the primary surgery a revision surgery and diar (debridement, antibiotics, irrigation, and retention) were performed due to suspected acute infection.The insert was revised.
 
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Brand Name
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/20MM
Common Device Name
KNEE TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key11654725
Report Number3005180920-2021-00290
Device Sequence Number3606444
Product Code JWH
UDI-Device Identifier07630030818097
UDI-Public07630030818097
Combination Product (Y/N)N
Initial Reporter CountryIS
PMA/510(K) Number
K103170
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 04/13/2021
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 Date08/19/2024
Device Model Number02.07.0420SCF
Device Catalogue Number02.07.0420SCF
Device Lot Number1906430
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/16/2021
Initial Report FDA Received Date04/13/2021
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;
Patient Age69 YR
Patient Weight88
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