MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; GMK-PRIMARY TIBIAL INSERT U.C. FIX S.2 / 10 MM

Model Number	02.07.0210FUC
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	02/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in reporting pain and instability the surgeon examined the joint and determined a revision of the poly and patella were needed.The patella implant was loose.At 13 years and 9 months post primary the surgeon revised the poly and patella and observed that the poly showed posterior lateral side wear.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 21 february 2025: (b)(4) items manufactured and released on 17-apr-2009.Expiration date: 2014-jan-31.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 implants also revised: gmk-primary 02.07.0034rp patella resurfacing s.2 (new generation) (k090988) lot.104490 batch review performed on 21 february 2025 (b)(4) items manufactured and released on 28-feb-2011.Expiration date: 2016-jan-31.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 r&d department: revision surgery of a gmk primary uc tibial insert after almost 14 years from primary implantation due to pain.During the revision surgery, the surgeon noticed posterior lateral wear of the insert with breakage of the posterior lip.Also, patella component was found loosened and replaced.From the picture of the explanted component, we can notice that the insert is broken in correspondence to the posterior lateral lip.The remaining part of the articular surface doesn't seem to be damaged or overly worn out.Reason for breakage is unknown.Wear and delamination can be a possible explanation.From the evidence in our hands it is not possible to assess if other particular conditions could have played a role in the process of wear, such as residual debris of cement detached from the patella or malrotation of the tibia baseplate.Wear can be expected after 14 years of implantation, but with available evidence, we can't assess that this was actually the real and only cause for the event.From preliminary investigation, there is no evidence that the event is related to a faulty device.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: GMK-PRIMARY TIBIAL INSERT U.C. FIX S.2 / 10 MM
• 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: 21560285
• Report Number: 3005180920-2025-00166
• Device Sequence Number: 18457063
• Product Code: JWH
• UDI-Device Identifier: 07630030816451
• UDI-Public: 07630030816451
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 03/03/2025

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: 01/31/2014
• Device Model Number: 02.07.0210FUC
• Device Lot Number: 090486
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2009
• 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