MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ L

Catalog Number	02.12.0024L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 september 2019: lot 181844: 27 items manufactured and released on 26-giu-2018.Expiration date: 2023-06-11.No anomalies found related to the problem.To date, 25 items of the same lot have been already sold without any other similar reported event.Additional implants involved in the event, batch review performed on 05 september 2019: gmk-sphere 02.07.1204l tibial tray fixed cemented size 4 l (k090988) lot.181930 lot 181930: 86 items manufactured and released on 26-giu-2018.Expiration date: 2023-06-17.No anomalies found related to the problem.To date, 77 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.179657 lot 179657: 125 items manufactured and released on 06-mar-2018.Expiration date: 2023-02-19.No anomalies found related to the problem.To date, 118 items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
Revision surgery performed after 1 year and 2 months from the last revision due to signs of an infection (the pathogen is unknown).The surgeon removed all hardware and implanted an antibiotic spacer successfully.
Event or Problem Description
Revision surgery performed after 1 year and 2 months from the last revision (b)(4) due to signs of an infection (the pathogen is unknown).The surgeon removed all hardware and implanted an antibiotic spacer successfully.On sept 28 the surgeon removed all hardware and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ L
• Common Device Name: FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9128596
• Report Number: 3005180920-2019-00812
• Device Sequence Number: 19481031
• Product Code: JWH
• UDI-Device Identifier: 07630030862397
• UDI-Public: 07630030862397
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2019

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 Date: 06/11/2023
• Device Catalogue Number: 02.12.0024L
• Device Lot Number: 181844
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 11/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR