MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; GMK-SPHERE PATELLA INSET Ø28MM

Model Number	02.07.0042IP
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	04/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 april 2025 lot 2300134: (b)(4) items manufactured and released on 19-may-2023.Expiration date: 2028-05-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Clinical evaluation: 6 months after primary cemented tkr, the patellar button gets loose and painful and needs revision.The cause is possibly the lateral position of the patella that is not properly oriented in the trochlear groove and may have caused lateral stresses.The patient is very heavy.According to report, only the patellar prosthesis has been replaced, and in absence of reorientation of the patella tracking or of the components the problem might present itself again in future.This kind of failure is not due to a defective device.Preliminary analysis performed by r&d knee department.A revision surgery was performed on the patellar component 6 months following its primary implantation due to implant loosening and associated pain.Upon examining the images related to the explanted component, no residual cement is visible on the implant.The peg is found to be broken.X-rays reveal that the patella is positioned laterally, and in extension, it is more laterally positioned than the femoral trochlea.The poor interdigitation between the cement and the implant is most likely attributable to issues during the cementation process.Once the implant became loosened, the absence of cement support for the patella resulted in the transmission of all shear loads to the peg.Over time, this led to deformation and eventual failure of the peg.Preliminary investigation shows no evidence suggesting that the failure is related to a faulty device.Although it cannot be confirmed, it is likely that the event was triggered by sub-optimal patella position combined with a cementation issue.The investigation does not indicate a potential manufacturing related issue or systemic deficiency.
Event or Problem Description
Revision surgery due to patella resurfacing mobilization, at about 6 months after primary.During the revision, the patellar implant was found with broken peg.Patellar implant successfully revised.
Additional Manufacturer Narrative
On june 3rd, 2025, the piece was returned for inspection.During a review of the case performed today, (b)(6) 2025, it was determined that the follow-up had not been sent to the fda due to an unintentional human error.The follow-up was mistakenly not opened in our system when the item returned and was analysed.Visual inspection performed by r&d knee department ((b)(6) 2025) a revision surgery was performed on the patellar component 6 months following its primary implantation due to implant loosening and associated pain.Upon examining the explanted component, no residual cement is visible on the implant.The peg is found to be broken.X-rays reveal that the patella is positioned laterally, and in extension, it is more laterally positioned than the femoral trochlea.The poor interdigitation between the cement and the implant is most likely attributable to issues during the cementation process.Once the implant became loosened, the absence of cement support for the patella resulted in the transmission of all shear loads to the peg.Over time, this led to deformation and eventual failure of the peg.Visual inspection shows no evidence suggesting that the failure is related to a faulty device.Root cause: although it cannot be confirmed, it is likely that the event was triggered by sub-optimal patella position combined with a cementation issue.The investigation does not indicate a potential manufacturing related issue or systemic deficiency.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE PATELLA INSET Ø28MM
• 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: 22010863
• Report Number: 3005180920-2025-00395
• Device Sequence Number: 5192737
• Product Code: JWH
• UDI-Device Identifier: 07630030815805
• UDI-Public: 07630030815805
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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): 08/11/2025

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 Model Number: 02.07.0042IP
• Device Lot Number: 2300134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2023
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 126 KG
• Patient Race: White