MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 R TINBN COATED

Model Number	02.07.2804R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Damage to Ligament(s) (1952)
Date of Event	12/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery for knee instability due ligament issue.The surgery was completed successfully.The surgeon is surprised that the cement has not stuck to the tibia.Competitor hinge system implanted in the patient.
Additional Manufacturer Narrative
Batch review performed on 03 january 2023: lot 174148: (b)(4) items manufactured and released on 06-dec-2017.Expiration date: 2022-11-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Clinical evaluation performed by medical affairs director: 9 months after primary cemented tka, the patient develops articvular instability and therefore exchange to a constrained device is undertaken.This is normal disease progression and there is no reason to suspect a faulty device at the origin of the revision surgery.The report mentions the absence of cement adhesion to the baseplate: this is due to cementation problems, such as late application of the cement to the metal baseplate, or possibly humidity on the surface, or temperature in the or being unexpectedly highr than usual: it is not a problem to ascribed to the implanted devices.Additional components involved in the event, batch review performed on 03 january 2023: gmk-sphere 02.12.0412fr tibial insert fixed sphere flex size 4/12 mm r (k121416) lot.2005756 lot 2005756: (b)(4) items manufactured and released on 11-aug-2020.Expiration date: 2025-07-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Gmk-sphere 02.12.0724r femoral component sphere tinbn coated size 4+ r (k202684) lot.2101863.Lot 2101863: (b)(4) items manufactured and released on 12-may-2021.Expiration date: 2026-04-21.No anomalies found related to the problem.To date, (b)(4) item of the same lot have been sold without any similar reported event in the period of review.
Additional Manufacturer Narrative
Preliminary investigation based on the pictures of the explanted femur and baseplate: residual cement can be seen on the internal surface of the femoral component.No residual cement can be seen on the explanted tibial baseplate.On the tibia side the cement remained most likely adherent to the bone.This is not an evidence of insufficient adhesion of the cement to the baseplate; and this is the case since the baseplate wasn't found loosened.Poor interdigitation between cement and implant surface is mostly influenced by many factors that are not implant related (cementation process, humidity on the implant surface, room temperature, etc.).  from preliminary investigation, there is no evidence that the event is related to a faulty device.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 R TINBN COATED
• Common Device Name: 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16157643
• Report Number: 3005180920-2022-00989
• Device Sequence Number: 20723671
• Product Code: JWH
• UDI-Device Identifier: 07630030821837
• UDI-Public: 07630030821837
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K202684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 01/17/2023

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: 11/26/2022
• Device Model Number: 02.07.2804R
• Device Catalogue Number: 02.07.2804R
• Device Lot Number: 174148
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2022
• Supplement Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2017
• 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: 68 YR
• Patient Sex: Unknown
• Patient Weight: 85 KG