MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 2 R; KNEE TIBIAL INSERT

Catalog Number	02.07.1202R
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	10/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
About 2 years and 4 months after the primary surgery, tibial tray and insert revised due to tibial tray loosening.
Additional Manufacturer Narrative
Batch review performed on 6 october 2023: lot 2001520: (b)(4) items manufactured and released on 15-jul-2020.Expiration date: 2025-jul-03.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 on 2 november 2023: at 2.5 years after primary cemented tka the tibial tray is found loose and needs revision.From the radiograph attached, a rather thick cement mantle is visible underneath the tray, something that could happen, for instance, if the cement cured faster than expected, or the tray was impacted later: in these conditions, the interdigitation of the cement in the metal structure is suboptimal and loosening is a possible consequence.We cannot state with certainty that this was the root cause for revision, but we think, based on experience, that it's a good possibility.

• Brand Name: GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 2 R
• Common Device Name: KNEE TIBIAL INSERT
• 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: 18063840
• Report Number: 3005180920-2023-00835
• Device Sequence Number: 7468408
• Product Code: JWH
• UDI-Device Identifier: 07630030819872
• UDI-Public: 07630030819872
• 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: 2021
• Device Explanted Year: 2023
• 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): 11/03/2023

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: 07/03/2025
• Device Catalogue Number: 02.07.1202R
• Device Lot Number: 2001520
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2020
• 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: 57 YR
• Patient Sex: Female