MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R

Model Number	02.12.0510FR
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 february 2025 lot 147287: (b)(4) items manufactured and released on 27/01/2015.Expiration date: 31/12/2019.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.R&d analysis: revision surgery of a gmk sphere component was performed due to anterior knee pain occurring 10 years after the primary tkr.During the initial surgery, the patella was not treated.However, in the revision procedure, the patella was resurfaced.The secure screw for the insert was found to be partially loosened, and the surgeon re-tightened it using the dedicated torque-limiting screwdriver.It is suspected that the screw loosening occurred due to insufficient torque during the primary surgery, as the torque-limiting screwdriver was not available to the surgeon at that time.Based on preliminary investigation, there is no indication that this issue is related to a defective device.The cause could be insufficient tightening torque at the time of primary operation, but this cannot be ascertained and other causes may have originated the issue.The device history record review does not indicate any potential manufacturing-related issue.
Event or Problem Description
About 9 years and 10 months after the primary surgery, the patient reported anterior knee pain and the surgeon performed an additional surgery and resurfaced patient natural patella.Inlay locking screw unscrewing (not free in the joint) was detected during this surgery.The inlay locking screw has been screwed back on.Torque limiter was not available during the primary surgery.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 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: 21717303
• Report Number: 3005180920-2025-00224
• Device Sequence Number: 4681957
• Product Code: JWH
• UDI-Device Identifier: 07630030826740
• UDI-Public: 07630030826740
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• 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): 03/28/2025

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: 12/31/2019
• Device Model Number: 02.12.0510FR
• Device Lot Number: 147287
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2015
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 98 KG