MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L; KNEE POLYETHYLENE TIBIAL INSERT

Catalog Number	02.12.0414FL
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07 jun 2019: lot 150409: (b)(4) items manufactured and released on 20-aug-2015.Expiration date: 2020-06-30.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 implant involved: gmk-sphere 02.12.0024l femoral component sphere cemented size 4+ l (k140826) lot.172747: (b)(4) items manufactured and released on 04-aug-2017.Expiration date: 2022-07-20.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.
Event or Problem Description
Revision surgery (washout and poly swap) has been performed on (b)(4) 2018, 5 months from the primary due to an infection (the pathogen unknown, the complaint: (b)(4), mdr: 2018-00330 was filed).Presently the second revision surgery has been performed after 1 year and 1 month from the last revision due to an infection (the pathogen is unknown).The surgeon revised the femoral component and the inlay and implanted antibiotic beads.
Additional Manufacturer Narrative
On july 18th 2019 we received this additional information: during the surgery on (b)(6) 2019, the patient came in due to signs of an infection.The surgeon decided to implant a femoral component and poly and cement them to the tibia to act as a "spacer".The surgeon also implanted antibiotic beads into the patient and prescribed the patient antibiotics for 6 weeks.On (b)(6) 2019, the surgeon removed all components from the patient and put in permanent hardware.The surgery was completed successfully.Please let me know if you need any additional information.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L
• Common Device Name: KNEE POLYETHYLENE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8699596
• Report Number: 3005180920-2019-00463
• Device Sequence Number: 2103211
• Product Code: JWH
• UDI-Device Identifier: 07630030826610
• UDI-Public: 07630030826610
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2019

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: 06/30/2020
• Device Catalogue Number: 02.12.0414FL
• Device Lot Number: 150409
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 06/14/2019
• Supplement Report FDA Received Date: 07/31/2019
• 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