MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; FEMUR SPHERE CEMENTED RIGHT, SIZE 2+

Model Number	02.12.0022R
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 18 december 2024: lot 2346925: (b)(4) items manufactured and released on 15-apr-2024.Expiration date: 2029-03-26.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.Two devices of the same lot involved in this complaint.Additional devices involved; batch review performed on 18 december 2024: instrument set gmk sphere femoral set s2+ ref 11.01112 lot 2343481: (b)(4) items manufactured and released on 05-dec-2023.Expiration date: 2028-11-19.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.Instrument involved gmk efficiency 77.11.1052 trial femoral component sphere s2+ r lot.Mat63606: 2800pcs and no anomalies found related to the problem.
Event or Problem Description
The trial fitted into the patient's prepared femur without any problems, but the implant with cement did not fit.The surgeon tried to hammer the implant, but there was a gap of 5 - 6mm, so the surgeon removed it.The surgeon tried another implants of the same lot to fit the femur, but it did not fit, too.The surgeon made an additional cut by free hand in the femur, recemented and placed another implant (same ref, different lot).The surgery was completed successfully.The delay time was 30 minutes.
Additional Manufacturer Narrative
Follow-up reason: section b5 updated according to the additional information received from the branch; devices were received and analyzed.Second femoral component tested and finally used: gmk-sphere 02.12.0022r femoral component sphere cemented size 2+ r lot.2412734.Batch review performed on 18 december 2024: lot 2412734: (b)(4) items manufactured and released on 15-jul-2024.Expiration date: 2029-jul-27.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.Visual inspection performed by medacta knee r&d project manager: intraoperative failure of fixation of the femoral implant in the first attempt of impaction as the implant didn't fit into the bone.It was necessary to re-cut 5-6mm more of femur bone to fit the implant.It was not possible to detect the problem through the efficiency trial of the same size.From visual inspection of the components (implant and trial) sent back for investigation, no anomalies can be identified.The trial component represents the final implant in terms of internal profile, articular surface and position of the pegs / holes.Reason for the event remains unknown.From visual inspection there is no evidence that the event is related to a faulty device.Based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the investigation does not indicate any potential manufacturing related issue.
Event or Problem Description
The trial fitted into the patient's prepared femur without any problems, but the implant with cement did not fit (lot 2346925).The surgeon tried to hammer the implant, but there was a gap of 5 - 6mm, so the surgeon removed it.The surgeon attempted to insert a second femur of the same reference but different lot (2412734) but he was not able to fit it in on the femur.So the surgeon made an additional cut by free hand in the femur, recemented and placed the second used femur tested before (2412734).The surgery was completed successfully.The delay time was 30 minutes.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: FEMUR SPHERE CEMENTED RIGHT, SIZE 2+
• 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: 21122125
• Report Number: 3005180920-2024-01125
• Device Sequence Number: 15664093
• Product Code: JWH
• UDI-Device Identifier: 07630030862366
• UDI-Public: 07630030862366
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.12.0022R
• Device Lot Number: 2346925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2024
• 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: Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian