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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FEMORAL COMPONENT SIZE 5 R; CONSTRAINED CEMENTED FEMORAL COMPONENT
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MEDACTA INTERNATIONAL SA GMK-HINGE FEMORAL COMPONENT SIZE 5 R; CONSTRAINED CEMENTED FEMORAL COMPONENT Back to Search Results
Model Number 02.09.2605R
Medical Device Problem Code Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 04/15/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 april 2021: lot 187996: (b)(4) items manufactured and released on 20-dec-2018.Expiration date: 2023-12-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
 
Event or Problem Description
Revision surgery 2 years after the primary due to femoral component loosening.Femoral component and tibial liner successfully revised.
 
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Brand Name
GMK-HINGE FEMORAL COMPONENT SIZE 5 R
Common Device Name
CONSTRAINED CEMENTED FEMORAL COMPONENT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key11805150
Report Number3005180920-2021-00379
Device Sequence Number14364193
Product Code KRO
UDI-Device Identifier07630030825484
UDI-Public07630030825484
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K130299
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 05/11/2021
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 Date12/05/2023
Device Model Number02.09.2605R
Device Catalogue Number02.09.2605R
Device Lot Number187996
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/15/2021
Initial Report FDA Received Date05/11/2021
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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