MAUDE Adverse Event Report: CORIN LTD (UK & FR) UNITY TOTAL KNEE SYSTEM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number 112.001.34

Device Problem Inaccurate Information (4051)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/10/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4) initial report: the reported confirmed that the part was not implanted.There was no impact to the patient.The reporter stated that the part was available to be returned.Conclusion of its review will be provided in a supplemental report.The appropriate device details were provided and the manufacturing records were identified.Conclusion of their review will be provided in a supplemental report.Please note: 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.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.

Event Description

A unity cr right femur size 6 was labeled as unity cr right femur size 7.

Manufacturer Narrative

(b)(4).Final report.The failure was confirmed on photos provided by the reporter.It was found that the 2 affected batches were packed into inner blister and outer blister consecutively by the same operator in the clean room.An internal project has been raised in order to identify the root cause and implement corrective/preventive actions.The project is still on-going.A recall was initiated in order to retrieve the non-implanted parts from the 2 affected batches.Based on this, this case is now considered closed.Please note: 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.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.

• Brand Name: UNITY TOTAL KNEE SYSTEM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): CORIN LTD (UK & FR); the corinium centre; love lane industrial estate; cirencester GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN LTD (UK & FR); corin medical; the corinium center; cirencester GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: marie-anne euzen ; the corinium center; cirencester GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 17647266
• MDR Text Key: 322287213
• Report Number: 9614209-2023-00228
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K113060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 112.001.34
• Device Lot Number: 532405
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 08/10/2023
• Initial Date Manufacturer Received: 08/10/2023
• Initial Date FDA Received: 08/29/2023
• Supplement Dates Manufacturer Received: 08/10/2023
• Supplement Dates FDA Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2023
• 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: UNITY FEMUR CR SIZE 6 PART 112.001.32 LOT 529803