MAUDE Adverse Event Report: Corin Ltd Unity Total Knee System; Unity Tibial Insert PS Fixed Size 5 12mm

Model Number	112.016.85
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	07/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Unity revision of the ps insert after approx.2 years due to instability.
Additional Manufacturer Narrative
(b)(4) initial report the following additional information has been requested in order to progress with the investigation of this event: - could they provide the operative reports for both the primary and revision procedures? - could they describe the reason for the reported instability? what was identified intra-operatively as the cause of the instability? - were the femoral and tibial components found to be well fixed and correctly positioned? were they retained during the revision? - why was only the tibial insert revised? was a different thickness implanted? - was the explanted insert found to be damaged or excessively worn? - could they provide the post-primary and pre-/post-revision x-rays, if available? however the reporter didn't respond.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.A review of the available manufacturing records did not identify any findings that could be associated with the reported instability.The reporter indicated in his report that the device was not available for return.Based on the available information, no further investigation can be conducted and the root cause has not been determined.This case is now considered closed 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: Unity Tibial Insert PS Fixed Size 5 12mm
• 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: 50098398
• Report Number: 9614209-2026-00077
• Device Sequence Number: 13341681
• Product Code: JWH
• UDI-Device Identifier: 05055343875391
• UDI-Public: 05055343875391
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K113060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/31/2026

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 Model Number: 112.016.85
• Device Catalogue Number: Not applicable
• Device Lot Number: 512890
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2026
• Initial Report FDA Received Date: 07/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female