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

Catalog Number	02.07.1204L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Laxity (4526); Implant Pain (4561)
Date of Event	07/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 2 years and 7 months after primary, the patient has been revised because of overhang of the tibial plate on the internal part.Moreover, the patient described anterior knee pain.The surgeon revised all the gmk sphere components and implantation of gmk-revision components with resurfacing of the patella bone.
Additional Manufacturer Narrative
Batch review performed on 02-aug-2024 lot 2013140: (b)(4) items manufactured and released on 25-aug-2021.Expiration date: 2026-07-27.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 medical affairs director.2.5 years after cemented tka the patient complains of anterior knee pain.In addition to that, medial tibial overhang and laxity are found by the surgeon at examination and imaging analysis.The patient shows the consequences of a former tibial fracture (date and description of event not known), we can't tell if it was prior to the primary tka or not and therefore we cannot assess relevance.Secondary laxity of the joint after tka is a known, possible evolution of the disease, mainly linked to progressive ligament laxity.It can also be related to a suboptimal choice of insert thickness at index surgery.Developmental anterior knee pain is often related to deterioration of the patellofemoral joint, that was not involved by the primary surgery (no patellar resurfacing had been performed).From all the above, there is no reason to suspect a malfunctioning or defective device.
Additional Manufacturer Narrative
Follow up 1: the event description has been modified the batch of lot 2013140 has been modified -the batches of lot 2110140 and 2107634 has been added as additional implants involved.Batch review performed on 05-nov-2024.Lot 2013140: (b)(4) items manufactured and released on 25-aug-2021.Expiration date: 2026-07-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event during the period of review.Additional implants involved; batch review performed on 05-nov-2024: gmk-sphere 02.12.0410fl tibial insert fixed sphere flex size 4/10 mm l (k121416) lot 2110140: (b)(4) items manufactured and released on 16-sep-2021.Expiration date: 2026-09-01.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Gmk-sphere 02.12.0004l femoral component sphere cemented size 4 l (k121416) lot 2107634: (b)(4) items manufactured and released on 29-jul-2021.Expiration date: 2026-07-15.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.There is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
At about 2 years and 7 months after primary, the patient has been revised because overhang of the tibial plate on the internal part and instability, especially in the medial region of the knee.Moreover, the patient described anterior knee pain.The surgeon revised all the gmk sphere components and implantation of gmk-revision components and resurfaced the patella bone.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L
• Common Device Name: KNEE 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: 20032989
• Report Number: 3005180920-2024-00663
• Device Sequence Number: 15056426
• Product Code: JWH
• UDI-Device Identifier: 07630030819902
• UDI-Public: 07630030819902
• 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: 2021
• 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,Followup
• Report Date (Section B): 11/05/2024

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: 07/27/2026
• Device Catalogue Number: 02.07.1204L
• Device Lot Number: 2013140
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/25/2021
• 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: 64 YR
• Patient Sex: Male