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

Catalog Number	02.12.0004L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 february 2019: lot 177994: (b)(4) items manufactured and released on 22-jan-2018.Expiration date: 2023-01-03.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.Additional components involved: gmk-sphere 02.12.T3i4l tibial tray fixed cemented # t3-i4 l, (k121416), lot 181874: (b)(4) items manufactured and released on 28-jun-2018.Expiration date: 2023-06-20.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.Gmk-sphere 02.12.0414fl tibial insert fixed sphere flex #4/14 mm l, (k121416), lot 166496: 50 items manufactured and released on 14-dec-2016.Expiration date: 2021-11-24.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.Clinical evaluation performed by medical affairs manager: early infection in cemented tka, 2 months after primary operation.Infection is a known possible adverse event following every surgery, including tka's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.Preliminary investigation performed by r&d knee manager: revision surgery after 2 months from primary implantation for loosening of the implant due to infection.From the picture of the explanted primary implant, no cement can be seen on the surface that were in contact with the bone.The cement remained adherent to the bone.Absence or lack of cement on explanted components is usual to be seen even if the cause of revision is not loosening or mobilization.Therefore this is not an evidence of lack of adhesion between the cement and the implant due to faulty devices.No non-conformity can be revealed in the distal surface of the component that could have contributed to the event.
Event or Problem Description
Revision surgery after 2 months from the primary due to loosening of the prosthesis caused by infection: epidermal staphylococcus found.Liner, femoral and tibial components have been revised.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 L
• Common Device Name: KNEE FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8381781
• Report Number: 3005180920-2019-00116
• Device Sequence Number: 1633678
• Product Code: JWH
• UDI-Device Identifier: 07630030825835
• UDI-Public: 07630030825835
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/01/2019

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: 01/03/2023
• Device Catalogue Number: 02.12.0004L
• Device Lot Number: 177994
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 03/01/2019
• 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: 68 YR
• Patient Weight: 74