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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 3+ R; KNEE FEMORAL COMPONENT
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MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R; KNEE FEMORAL COMPONENT Back to Search Results
Model Number 02.12.0023R
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 06/11/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 june 2020: lot 167373: (b)(4) items manufactured and released on 20-mar-2017.Expiration date: 2022-03-08.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
2 years and 10 months after primary the patient came in reporting instability due to a loose femoral component.3 years post primary the surgeon revised the femoral component and poly and the surgery was completed successfully.
 
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Brand Name
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R
Common Device Name
KNEE FEMORAL COMPONENT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874, CHE
CH  6874, CHE
MDR Report Key10257287
Report Number3005180920-2020-00400
Device Sequence Number19603900
Product Code JWH
UDI-Device Identifier07630030862380
UDI-Public07630030862380
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K140826
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/10/2020
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 No Information
Device Expiration Date03/08/2022
Device Model Number02.12.0023R
Device Catalogue Number02.12.0023R
Device Lot Number167373
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/12/2020
Initial Report FDA Received Date07/10/2020
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;
Patient Age77 YR
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