MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JUNI OX FB FEM SZ 7 RM LL; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71422357

Device Problem Connection Problem (2900)

Patient Problem Failure of Implant (1924)

Event Date 03/29/2021

Event Type  Injury  

Event Description

It was reported that, after a navio assisted unicondylar knee replacement, the patient collapsed into valgus.Implants were revised to a legion hinge with cones and stems.Patient outcome is unknown.

Manufacturer Narrative

H6: the affected complaint device, used in treatment, was not returned for evaluation.Therefore, a product analysis could not be performed.There is no information that would suggest the device failed to meet specifications.A review of complaint history revealed no prior complaints for the listed part.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore, no medical assessment can be performed at this time.The potential probable causes for this event could include but not limited to patients condition, user or procedural error.Based on this investigation, the need for corrective action is not indicated.A review of risk management files and the instructions for use found that the probable cause failures were documented appropriately.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H3, h6: ¿the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per the complaint details, a patient required a revision surgery at least 3 months post uni-knee replacement due to ¿collapsing into valgus¿.Reportedly, the revision was a conversion to a hinged knee with cones and stems.It was communicated that the requested clinical information was not available.However, it was verified per correspondence that the usage of the navio did not contribute to the reported events.S+n has not received the device and/or adequate documentation to fully evaluate the root cause of the reported events.The patient impact beyond the reported uni-knee failure/¿collapse into valgus¿ and subsequent revision/conversion could not be determined.No further medical assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed device for the same failure mode.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to procedural/user error, surgical complication or patient medical history.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.¿.

• Brand Name: JUNI OX FB FEM SZ 7 RM LL
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11720856
• MDR Text Key: 247221936
• Report Number: 1020279-2021-03395
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 03596010627438
• UDI-Public: 03596010627438
• Combination Product (y/n): N
• PMA/PMN Number: K073175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71422357
• Device Catalogue Number: 71422357
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention