MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; GMK-SPHERE TIBIAL TRAY FIXED CEMENTED

Model Number	02.07.1202L
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30-sep-2024: lot 1908611: (b)(4) items manufactured and released on 11-dec-2019.Expiration date: 2024-12-01.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 device involved: batch review performed on 30-sep-2024: gmk-sphere 02.07.0035rp patella resurfacing size 3 (k090988) lot 1908305: (b)(4) items manufactured and released on 31-oct-2019.Expiration date: 2024-10-15.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.Clinical evaluation performed by medacta medical affairs director: 4.5 years after revision tka, due to infection, the tibial tray gets loose and the patient is symptomatic.A revision system is implanted because the bone condition, which has worsened (possibly following the secondary infection) is deemed to be insufficient for a stemless system to be implanted , and a higher degree of constraint is wished by the surgeon.The resurfacing patella is found loose too, reinforcing the idea that the bone in the knee may have weakened after the infection onset.No defect of the implants was reported.
Event or Problem Description
On the (b)(6) 2020, the patient underwent a primary surgery, with gmk-sphere components and patella resurfacing implantation.On the (b)(6) 2021, the patient came reporting pain and infection was detected.The surgeon revised successfully the tibial insert.Presently, on the (b)(6) 2024, the patient came reporting pain and loosening of the tibial tray was detected.During the revision surgery also patella implant loosening was noticed.The surgeon revised successfully all the gmk-sphere components and implanted gmk-revision system with a new patella implant.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED
• 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: 20514138
• Report Number: 3005180920-2024-00840
• Device Sequence Number: 9232362
• Product Code: JWH
• UDI-Device Identifier: 07630030819865
• UDI-Public: 07630030819865
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/23/2024

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: 12/01/2024
• Device Model Number: 02.07.1202L
• Device Lot Number: 1908611
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 73 KG