MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 3/11 MM R

Model Number	02.12.0311FR
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 may 2021: lot 1906890: (b)(4) items manufactured and released on 20-sep-2019.Expiration date: 2024-09-01.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.Lot 1901837: (b)(4) items manufactured and released on 25-jun-2019.Expiration date: 2024-06-11.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.Lot 1905247: (b)(4) items manufactured and released on 03-dec-2019.Expiration date: 2024-11-23.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
The patient had a primary knee surgery on (b)(6) 2020.On (b)(6) 2020, the patient came in due to signs of an infection.The surgeon performed an i&d and revised the sphere insert flex right 11mm s3 with a sphere insert flex right 11mm s3.The surgery was completed successfully.Currently on (b)(6) 2021, 1 year and 2 months after the primary surgery, the patient came in due to signs of an infection.The surgeon performed an i&d and revised all components.The surgery was completed successfully.
Event or Problem Description
The patient had a primary knee surgery on (b)(6) 2020.On (b)(6) 2020, the patient came in due to signs of an infection.The surgeon performed an i&d and revised the sphere insert flex right 11mm s3 with a sphere insert flex right 11mm s3.The surgery was completed successfully.On (b)(6) 2021, 1 year and 2 months after the primary surgery, the patient came in due to signs of an infection.The surgeon performed an i&d and put a temporary spacer (revised all the components).The surgery was completed successfully.
Additional Manufacturer Narrative
Event description was corrected based on the new information received on august 09, 2021: the patient had a primary knee surgery on (b)(6) 2020.On (b)(6) 2020, the patient came in due to signs of an infection.The surgeon performed an i&d and revised the sphere insert flex right 11mm s3 with a sphere insert flex right 11mm s3.The surgery was completed successfully.On (b)(6) 2021, 1 year and 2 months after the primary surgery, the patient came in due to signs of an infection.The surgeon performed an i&d and put a temporary spacer (revised all the components).The surgery was completed successfully.On (b)(6) 2021, the surgeon removed the spacer and put in permanent hardware in addition, here below there are the other items involved in the event with k-numbers, references and description.The batch review was already reported in the initial.Gmk-sphere 02.12.0003r femoral component sphere cemented size 3 r (k121416) lot.1901837.Gmk-sphere 02.07.1203r tibial tray fixed cemented size 3 r (k090988) lot.1905247.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 3/11 MM R
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11907495
• Report Number: 3005180920-2021-00453
• Device Sequence Number: 1296731
• Product Code: JWH
• UDI-Device Identifier: 07630030862588
• UDI-Public: 07630030862588
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2021

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: 09/01/2024
• Device Model Number: 02.12.0311FR
• Device Catalogue Number: 02.12.0311FR
• Device Lot Number: 1906890
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 05/03/2021
• Initial Report FDA Received Date: 05/31/2021
• Supplement Report FDA Received Date: 09/09/2021
• 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: 65 YR