MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM R; KNEE TIBIAL INSERT

Catalog Number	02.12.0310FR
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	07/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery performed 1 year 5 months after the primary due to significant knee stiffness with maximum flexion at 20 degrees.Anterior pain described by the patient.No implant loosening.No infections.The surgeon revised successfully gmk-sphere system to gmk-revision and resurfaced the natural patella.
Additional Manufacturer Narrative
Batch review performed on 10 july 2023: lot 2112437: (b)(4) items manufactured and released on 18-oct-2021.Expiration date: 2026-10-04.No anomalies found related to the problem.To date, 142 items of the same lot have been sold without any similar reported event during the period of review.Additional devices involved batch review performed on (b)(4) 2023.Gmk-sphere 02.07.1203r tibial tray fixed cemented size 3 r (k090988) lot 2109864: (b)(4) items manufactured and released on 16-nov-2021.Expiration date: 2026-11-16.No anomalies found related to the problem.To date, 97 items of the same lot have been sold without any similar reported event during the period of review.Gmk-sphere 02.12.0003r femoral component sphere cemented size 3 r (k121416) lot 2110987: (b)(4) items manufactured and released on 05-oct-2021.Expiration date: 2026-09-21.No anomalies found related to the problem.To date, 47 items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation: a revision surgery was performed 1,5 year after the first implant of a gmk sphere without resurfacing patella, using myknee instruments.The patient complained of anterior knee pain and joint stiffness (with maximum flexion at 20°).From the available x ray images, we can assess a mild subsidence of the tibial tray medially and anteriorly and no loosening.Also, we can observe a patella baja that may be accounted among the causes of anterior knee pain and restricted range of motion.We have no reason to suspect a defective or malfunctioning device.The revision surgery provided the implant of a gmk revision with resurfacing patella.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM 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: 17388489
• Report Number: 3005180920-2023-00567
• Device Sequence Number: 6072484
• Product Code: JWH
• UDI-Device Identifier: 07630030826344
• UDI-Public: 07630030826344
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121416
• 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): 07/25/2023

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: 10/04/2026
• Device Catalogue Number: 02.12.0310FR
• Device Lot Number: 2112437
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2023
• Initial Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2021
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 75 KG