MAUDE Adverse Event Report: CORIN LTD (UK) UNIGLIDE; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 515.0600

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 10/26/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report.Additional information, including if a revision occurred, and in that case the date of the revision, device details of any other relevant corin devices and what devices were revised, post primary and pre revision x-rays, operative notes (primary and revision), patient information, whether the patient experiencedany slips / trips or other trauma post primarysurgery, if the patient followed correct post-op protocal and an update on the patient post revision, has been requested in order to progress with the investigation of this event.If received, it will be provided in the next report.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.

Event Description

Suspected uniglide revision due to pain and restricted movement.

Event Description

Uniglide revision due to fracture of the insert.

Manufacturer Narrative

(b)(4) final report - additional information, including if a revision occurred, and in that case the date of the revision, device details of any other relevant corin devices and what devices were revised, post primary and pre revision x-rays, operative notes (primary and revision), patient information, whether the patient experienced any slips / trips or other trauma post primary surgery, if the patient followed correct post-op protocol, an update on the patient post revision and if the explanted parts were available for return, has been requested in order to progress with the investigation of this event.Revision operative notes, pre revision x-ray and a picture of the explants were provided, reviewed and confirmed the fracture of the insert.The explants were confirmed not available for return to corin vigilance.The appropriate explanted device details were provided and the relevant device manufacturing records have been identified.Review of these records revealed no product non-conformity or deviation from process that would have caused or contributed to the reported fracture.Based on the available information, no further investigation can be conducted and the root cause of the reported fracture could not be identified.This case is now considered closed.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: UNIGLIDE
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): CORIN LTD (UK); the corinium centre; cirencester GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN LTD (UK); the corinium centre; cirencester; cirencester GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: dardan uka ; the corinium centre; cirencester; gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 18237882
• MDR Text Key: 329375981
• Report Number: 9614209-2023-00271
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K050764
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 02/15/2015
• Device Model Number: 515.0600
• Device Lot Number: 162868
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/24/2023
• Date Manufacturer Received: 11/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNIGLIDE INSERT 530.0304, 163682; UNIGLIDE TIBIAL TRAY 524.1400, 163450
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 72 KG