MAUDE Adverse Event Report: Corin Ltd Unity Total Knee System; Tibial Insert CR Fixed Size 5 9mm

Model Number	112.014.82
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Unity revision of the cr insert after approx.4 years due to infection (omnibotics used in primary).
Additional Manufacturer Narrative
Per (b)(4) initial report.The following additional information has been requested in order to progress with the investigation of this event: - confirmation of the usage for the primary surgery.- patient age, activity level, weight.- has the patient undergone any recent procedures / treatments that may have caused the reported infection? - was the unity knee cr tibial insert exchanged during the dair procedure? if yes, why was it replaced? - an update on the patient post revision.If received, this will be provided in a supplemental report upon completion of the investigation: the appropriate device details have been provided and the relevant device manufacturing records will be identified and reviewed.Please note: this report is filed with the fda due to an adverse event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.

• Brand Name: Unity Total Knee System
• Common Device Name: Tibial Insert CR Fixed Size 5 9mm
• Manufacturer (Section D): Corin Ltd; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): Corin Ltd; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: franck didier ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 50927734
• Report Number: 9614209-2026-00127
• Device Sequence Number: 15875278
• Product Code: JWH
• UDI-Device Identifier: 05055343874691
• UDI-Public: 05055343874691
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• 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): 09/29/2026

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: 10/04/2025
• Device Model Number: 112.014.82
• Device Catalogue Number: not applicable
• Device Lot Number: 461184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/13/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OMNIbotics Station Cart: NV-CRT01, lot: N/A.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown