MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R

Model Number	02.12.0412FR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Laxity (4526); Implant Pain (4561)
Date of Event	10/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 3 years and 2 months after primary, the patient came in reporting patella pain and instability and the cause is unknown.The surgeon revised the patella implant and revised the insert (12mm) with a thicker one (14mm).The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 22-oct-2024.Lot 2012708: (b)(4) items manufactured and released on 29-jan-2021.Expiration date: 2026-01-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Additional implant involved, batch review performed on 22-oct-2024.Gmk-sphere 02.07.0034rp patella resurfacing size 2 (k090988) lot 2100297: (b)(4) items manufactured and released on 25-mar-2021.Expiration date: 2026-03-11.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.The surgeon revised liner height, which is a common practice to restore the joint stability.While regarding the patella pain, based on the information available, no definitive root cause can be established.There is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R
• 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: 20681572
• Report Number: 3005180920-2024-00931
• Device Sequence Number: 7440409
• Product Code: JWH
• UDI-Device Identifier: 07630030826580
• UDI-Public: 07630030826580
• 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: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2024

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: 01/12/2026
• Device Model Number: 02.12.0412FR
• Device Lot Number: 2012708
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2021
• 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: Female
• Patient Race: White