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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 4; KNEE FEMORAL CEMENTED COMPONENT
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MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 4; KNEE FEMORAL CEMENTED COMPONENT Back to Search Results
Catalog Number 02.12.0004R
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 02/04/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 march 2019: lot 166912: (b)(4) items manufactured and released on 06-feb-2017.Expiration date: 2022-01-25.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, 2 years after primary surgery, due to instability caused by a loose femoral component.The femoral component, tibial tray and tibial insert have been revised.
 
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Brand Name
GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 4
Common Device Name
KNEE FEMORAL CEMENTED COMPONENT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key8394716
Report Number3005180920-2019-00121
Device Sequence Number18892098
Product Code JWH
UDI-Device Identifier07630030825842
UDI-Public07630030825842
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 Year2017
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 03/06/2019
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 Date01/25/2022
Device Catalogue Number02.12.0004R
Device Lot Number166912
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/04/2019
Initial Report FDA Received Date03/06/2019
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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