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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+ L; KNEE FEMORAL COMPONENT
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MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 4+ L; KNEE FEMORAL COMPONENT Back to Search Results
Model Number 02.12.0024L
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 05/29/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 10 june 2020: lot 188923: (b)(4) items manufactured and released on 15-jan-2019.Expiration date: 2023-12-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional devices involved: batch reviews performed by medacta regulatory affairs department on 10 june 2020: gmk-sphere 02.07.1204l tibial tray fixed cemented size 4 l (k090988) lot 1902683: (b)(4) items manufactured and released on 13-aug-2019.Expiration date: 2024-07-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Gmk-sphere 02.12.0410fl tibial insert fixed sphere flex size 4/10 mm l (k121416) lot 1903253: (b)(4) items manufactured and released on 03-jul-2019.Expiration date: 2024-06-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Gmk-sphere 02.07.0034rp patella resurfacing size 2 (k090988) lot 1902820: (b)(4) items manufactured and released on 27-jun-2019.Expiration date: 2024-06-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medacta medical affairs director: few months after primary cemented tka an infection developed and led to revision.No reason to suspect a faulty device.
 
Event or Problem Description
Revision surgery performed 7 months after the primary surgery due to an infection (pathogen unknown).All implants reported were revised.
 
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Brand Name
GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 4+ L
Common Device Name
KNEE FEMORAL COMPONENT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key10194903
Report Number3005180920-2020-00362
Device Sequence Number2561051
Product Code JWH
UDI-Device Identifier07630030862397
UDI-Public07630030862397
Combination Product (Y/N)N
Initial Reporter CountrySZ
PMA/510(K) Number
K140826
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 06/25/2020
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 Date12/13/2023
Device Model Number02.12.0024L
Device Catalogue Number02.12.0024L
Device Lot Number188923
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/29/2020
Initial Report FDA Received Date06/25/2020
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 Weight80
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