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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L
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MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L Back to Search Results
Catalog Number 02.12.0025L
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 10/08/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21 october 2019: lot 178023: (b)(4) items manufactured and released on 12-feb-2018.Expiration date: 2023-01-29.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.Other devices involved in the event: gmk-sphere 02.07.1204l tibial tray fixed cemented size 4 l lot.178623 (k090988).Batch review performed on 21 october 2019: lot 178623: (b)(4) items manufactured and released on 07-mar-2018.Expiration date: 2023-02-22.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.Gmk-sphere 02.12.0412fl tibial insert fixed sphere flex size 4/12 mm l lot.178747 (k121416) batch review performed on 21 october 2019: lot 178747: (b)(4) items manufactured and released on 22-mar-2018.Expiration date: 2023-03-11.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
Revision surgery performed after 1 year after the primary due to signs of an infection and the pathogen is unknown.The surgeon revised the femur, tibia and insert components and implanted an articulating spacer.The surgery was completed successfully.
 
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Brand Name
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L
Common Device Name
FEMORAL COMPONENT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key9278377
Report Number3005180920-2019-00940
Device Sequence Number14100397
Product Code JWH
UDI-Device Identifier07630030862410
UDI-Public07630030862410
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K140826
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2019
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 11/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date01/29/2023
Device Catalogue Number02.12.0025L
Device Lot Number178023
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/09/2019
Initial Report FDA Received Date11/05/2019
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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