MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM L; KNEE TIBIAL INSERT PE

Model Number	02.12.0412FL
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 6 months after the primary, the patient came in reporting instability and due to signs of an infection.The reason for the instability and pathogen is unknown.The surgeon performed a washout and revised the gmk-sphere tibial insert (12 mm to 13mm to improve the stability knee in per-op).The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 04 august 2022.Lot 180925: 25 items manufactured and released on 29-may-2018.Expiration date: 2023-05-14.No anomalies found related to the problem.To date, 22 items of the same lot have been sold with another similar reported event during the period of review.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM L
• Common Device Name: KNEE TIBIAL INSERT PE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15273673
• Report Number: 3005180920-2022-00634
• Device Sequence Number: 6237650
• Product Code: JWH
• UDI-Device Identifier: 07630030826573
• UDI-Public: 07630030826573
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 08/23/2022

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 Model Number: 02.12.0412FL
• Device Catalogue Number: 02.12.0412FL
• Device Lot Number: 180925
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2022
• Initial Report FDA Received Date: 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2018
• 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 Sex: Male