MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L; KNEE FEMORAL COMPONENT CEMENTED

Catalog Number	02.12.0025L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 apr 2019: lot 151966: (b)(4) items manufactured and released on 22-apr-2015.Expiration date: 2020-03-31.No anomalies found related to the problem.To date, (b)(4) items of this same lot have been already sold without any other similar reported event.Additional implants involved in the event: gmk-sphere 02.12.0510fl tibial insert fixed sphere flex size 5/10 mm l (k121416), lot 179665: (b)(4) items manufactured and released on 06-mar-2018.Expiration date: 2023-02-18.No anomalies found related to the problem.To date, (b)(4) items of this same lot have been already sold without any other similar reported event.Gmk-sphere 02.07.0035rp patella resurfacing size 3 (k090988), lot 175542: (b)(4) items manufactured and released on 12-dec-2017.Expiration date: 2022-11-27.No anomalies found related to the problem.To date, (b)(4) items of this same lot have been already sold without any other similar reported event.Gmk-sphere 02.07.1205l tibial tray fixed cemented size 5 l (k090988), lot 178625: (b)(4) items manufactured and released on 27-feb-2018.Expiration date: 2023-02-13.No anomalies found related to the problem.To date, (b)(4) items of this same lot have been already sold without any other similar reported event.Clinical evaluation performed by medical affairs manager: infection in cemented tka, 11 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.
Event or Problem Description
On april 1st we were alerted of a knee infection, the revision surgery was performed successfully on april 3rd, about 1 year after primary.All hardware were explanted and an antibiotic spacer was put in.The patients was first noted to have an infection at the 4th week post surgery.The first swab results came back as a staph aureus infection.The patient has had multiple surgeries since to wash the knee out and to try to remove the infection.
Additional Manufacturer Narrative
Visual inspection performed by r&d knee manager: revision surgery of a gmk sphere implant one year after primary surgery due to infection.Event is not implant related.No element relevant for the analysis and for the event can be detected by the visual inspection of the explanted components (tibial inlay, tibial tray and femoral component).
Additional Manufacturer Narrative
On (b)(6) 2019 we were informed that: on the (b)(6) 2019 the surgery was completed at (b)(6) by (b)(6).Femur and tibia (final implants) were inserted into the patient.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ 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: 8564993
• Report Number: 3005180920-2019-00325
• Device Sequence Number: 11317836
• Product Code: JWH
• UDI-Device Identifier: 07630030862410
• UDI-Public: 07630030862410
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2019

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: 03/31/2020
• Device Catalogue Number: 02.12.0025L
• Device Lot Number: 151966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 04/01/2019; 04/01/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 05/28/2019; 07/30/2019
• 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: 57 YR