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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 3 R; KNEE CEMENTED FEMUR
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MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 3 R; KNEE CEMENTED FEMUR Back to Search Results
Model Number 02.12.0003R
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 10/26/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 november 2020: lot 1909467: 45 items manufactured and released on 26-feb-2020.Expiration date: 2025-02-16.No anomalies found related to the problem.To date,31 items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
Revision surgery for too much knee femur valgus position 3 months after primary surgery.The surgeon revised the femoral component and insert and the surgery was completed successfully.
 
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Brand Name
GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 3 R
Common Device Name
KNEE CEMENTED FEMUR
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key10895800
Report Number3005180920-2020-00839
Device Sequence Number16951017
Product Code JWH
UDI-Device Identifier07630030825828
UDI-Public07630030825828
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K121416
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
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) 11/24/2020
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 Date02/16/2025
Device Model Number02.12.0003R
Device Catalogue Number02.12.0003R
Device Lot Number1909467
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/26/2020
Initial Report FDA Received Date11/24/2020
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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