MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/17 MM R; KNEE TIBIAL INSERT POLYETHYLENE

Catalog Number	02.12.0517FR
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 december 2023.Lot 1900429: (b)(4) items manufactured and released on 23-may-2019.Expiration date: 2024-05-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event during the period of review.Additional involved implant.Batch review performed on 04 december 2023 on gmk-sphere 02.12.0517fr tibial insert fixed sphere flex size 5/17 mm r (k121416) lot 2238855: (b)(4) items manufactured and released on 10-nov-2022.Expiration date: 2027-10-30.No anomalies found related to the problem.To date, (b)(4) item of the same lot has been sold without any similar reported event during the period of review.
Event or Problem Description
The patient had a primary surgery on (b)(6) 2023.On (b)(6) 2023, the patient came in reporting signs of an infection and the pathogen is unknown.The surgeon performed a washout and poly-swap and inserted antibiotic beads.The surgery was completed successfully.Presently, on (b)(6) 2023, another washout and poly-swap was performed.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/17 MM R
• Common Device Name: KNEE TIBIAL INSERT POLYETHYLENE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18272886
• Report Number: 3005180920-2023-00971
• Device Sequence Number: 3954464
• Product Code: JWH
• UDI-Device Identifier: 07630030826863
• UDI-Public: 07630030826863
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2023

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: 05/08/2024
• Device Catalogue Number: 02.12.0517FR
• Device Lot Number: 1900429
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male