MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM L; FIXED TIBIAL INSERT

Model Number	02.12.0512FL
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	05/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 june 2020: lot 1904545: (b)(4) items manufactured and released on 22-july-2019.Expiration date: 2024-07-06.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 02.12.0025l femoral component sphere cemented size 5+ l (k140826) lot.1903624.Batch review performed on 08 june 2020: lot 1903624: (b)(4) items manufactured and released on 13-ago-2019.Expiration date: 2024-07-24.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.
Event or Problem Description
The patient came in reporting an inability to achieve full extension after hearing a popping sound during rehab.3 months after primary the surgeon revised the femoral component, resected more the distal femur and revised the insert to a thinner one.The surgery was completed successfully.The reason of popping sound is unknown.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM L
• Common Device Name: FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10198975
• Report Number: 3005180920-2020-00357
• Device Sequence Number: 2297131
• Product Code: JWH
• UDI-Device Identifier: 07630030826771
• UDI-Public: 07630030826771
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2020

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: 07/06/2024
• Device Model Number: 02.12.0512FL
• Device Catalogue Number: 02.12.0512FL
• Device Lot Number: 1904545
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 06/26/2020
• 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: 73 YR