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

Catalog Number	02.07.1204R
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was revised at about 1 year and 8 months post primary for tibial tray loosening.All the implants were exchanged to a competitor semi-constrained system.No cement found under the tibial implant.
Additional Manufacturer Narrative
Batch review performed on 13 december 2023: lot 2114774: (b)(4) items manufactured and released on 14-feb-2022.Expiration date: 2027-01-26.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.Preliminary investigation performed by r&d project manager: from preliminary investigation based on the pictures of the removed components, no residual cement can be noted on the distal surface of tibial baseplate and on the internal surfaces of the femoral component.Poor interdigitation between cement and implant can be related to multiple factors, most likely not implant related (such as cementation process, temperature, time, presence of fluids on the surfaces of cement interface) absence of cement, is not an evidence of a faulty device.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
• Common Device Name: KNEE CEMENTED TIBIAL TRAY
• 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: 18383093
• Report Number: 3005180920-2023-01045
• Device Sequence Number: 7712917
• Product Code: JWH
• UDI-Device Identifier: 07630030819919
• UDI-Public: 07630030819919
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 12/22/2023

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 Catalogue Number: 02.07.1204R
• Device Lot Number: 2114774
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2022
• 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: 55 YR
• Patient Sex: Female
• Patient Weight: 85 KG