MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE EXTENSION STEM - FLUTED Ø 15 L 65; EXTENSION STEM FLUTED

Catalog Number	02.07.FCL15065
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 5 july 2019: lot 162544: (b)(4) items manufactured and released on 25 august 2016.Expiration date: 2021-07-27.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 implants involved in the event, batch review performed on 5 july 2019: gmk-sphere 02.12.0025l femoral component sphere cemented size 5+ l (k140826) lot.178702.Lot 178702: (b)(4) items manufactured and released on 5 march 2018.Expiration date: 2023-02-09.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-revision 02.07.0685l revision fixed tibial tray cemented size 5 l (k123721) lot.180458 lot 180458: (b)(4) items manufactured and released on 16 april 2018.Expiration date: 2023-04-05.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 02.12.0512fl tibial insert fixed sphere flex size 5/12 mm l (k121416) lot.183026.Lot 183026: (b)(4) items manufactured and released on 16 april 2018.Expiration date: 2023-06-24.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.Gmk-revision 02.09.Ta510 tibial augmentation size 5/10mm (k130299) lot.146738.Lot 146738: (b)(4) items manufactured and released on 14 november 2014.Expiration date: 2019-09.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-revision 02.09.Ta510 tibial augmentation size 5/10mm (k130299) lot.148091.Lot 148091: (b)(4) items manufactured and released on 11 march 2015.Expiration date: 2020-01.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.
Event or Problem Description
1 year and 1 month after the primary surgery the patient complaint of instability and aseptic loosening of the tibial tray and subsequently, the surgeon revised the tibial tray and poly, complaint was filed.24 days after the first revision surgery has been performed the second revision surgery due to and infection ((b)(6)).The surgeon subsequently performed a washout and a poly swap on (b)(6) 2018, complaint was filed.Presently, 4 months from the second revision surgery, the patient came in due to signs of infection (the pathogen is unknown).The surgeon performed a washout and removed all implants and implanted an antibiotic spacer.The surgery was completed successfully.
Event or Problem Description
On (b)(6), the patient had permanent hardware implanted and had the antibiotic spacer removed.

• Brand Name: GMK-SPHERE EXTENSION STEM - FLUTED Ø 15 L 65
• Common Device Name: EXTENSION STEM FLUTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8816203
• Report Number: 3005180920-2019-00596
• Device Sequence Number: 2348400
• Product Code: JWH
• UDI-Device Identifier: 07630030822995
• UDI-Public: 07630030822995
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120790
• 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): 10/24/2019

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: 07/27/2021
• Device Catalogue Number: 02.07.FCL15065
• Device Lot Number: 162544
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 10/24/2019
• 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