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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 2+ L LOT.; KNEE FEMORAL CEMENTED COMPONENT
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MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ L LOT.; KNEE FEMORAL CEMENTED COMPONENT Back to Search Results
Catalog Number 02.12.0022L
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 05/14/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07 jun 2019: lot 154720: (b)(4) items manufactured and released on 20-oct-2015.Expiration date: 2020-10-06.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.Additional implants involved: gmk-sphere 02.07.1202l tibial tray fixed cemented size 2 l (k090988) lot 155596: (b)(4) items manufactured and released on 12-jan-2016.Expiration date: 2020-12-07.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 02.12.0210fl tibial insert fixed sphere flex size 2/10 mm l (k121416) lot 154730: (b)(4) items manufactured and released on 04-jan-2016.Expiration date: 2020-12-09.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 4 months from the primary due to mid-flexion instability.The surgeon revised the femoral component, tibial tray, and poly.The surgery was completed successfully.
 
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Brand Name
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ L LOT.
Common Device Name
KNEE FEMORAL CEMENTED COMPONENT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key8695292
Report Number3005180920-2019-00460
Device Sequence Number19316685
Product Code JWH
UDI-Device Identifier07630030862472
UDI-Public07630030862472
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K140826
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 06/13/2019
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 Date10/06/2020
Device Catalogue Number02.12.0022L
Device Lot Number154720
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/14/2019
Initial Report FDA Received Date06/13/2019
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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