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

Model Number	02.12.0024R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 february 2020: lot 168771: (b)(4) items manufactured and released on 08-feb-2017.Expiration date: 2022-01-29.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event.Preliminary investigation performed by the r&d knee manager: revision surgery after 2 years from primary implantation due to infection.Looking at the explanted components, any non-conformity can be noted.There is no evidence that the event is related to a faulty device.Infection is a known possible adverse event following tka's.Additional implants involved in the event, batch review performed on 12 february 2020: gmk-sphere 02.12.0410fr tibial insert fixed sphere flex size 4/10 mm r (k121416).Lot 170327: (b)(4) items manufactured and released on 11-apr-2017.Expiration date: 2022-03-23.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event.Gmk-sphere 02.12.T3i4r tibial tray fixed cemented size t3-i4 r (k121416).Lot 171841: (b)(4) items manufactured and released on 12-jul-2017.Expiration date: 2022-06-29.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.
Event or Problem Description
Revision surgery due to a sepsis 2 years and 2 months after primary.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ R
• Common Device Name: KNEE FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9792949
• Report Number: 3005180920-2020-00122
• Device Sequence Number: 2288768
• Product Code: JWH
• UDI-Device Identifier: 07630030862403
• UDI-Public: 07630030862403
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2020

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 Date: 01/29/2022
• Device Model Number: 02.12.0024R
• Device Catalogue Number: 02.12.0024R
• Device Lot Number: 168771
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 03/05/2020
• 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: 76 YR
• Patient Weight: 93