MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JUNI OX FB FEM SZ 4 LM RL; PRSTHSSKNEEFMRTIBLNN-CNSTRINDCMNTDMTALPLYMR

Model Number 71422344

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

Patient Problem Injury (2348)

Event Date 11/27/2019

Event Type  Injury  

Event Description

It was reported that patient had a ukr, whilst implanting the femur the surgeon noticed femoral component was sitting too flexed.Unsure of how this occurred, possibly due to the cuts made through the 2:1 cutting block.This was causing an impingement on the patella.Surgeon down sized and used a size 3 uni-component instead.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation, the reported event could not be confirmed.The clinical/medical team concluded, without the requested clinical information a thorough medical investigation cannot be rendered.It was communicated that there was a delay of 30 minutes and no patient harm was report due to the additional surgical time.Should any additional clinical information be provided this complaint will be re-evaluated.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A review of complaint history for the listed part revealed no prior complaints for the listed batch.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.

• Brand Name: JUNI OX FB FEM SZ 4 LM RL
• Type of Device: PRSTHSSKNEEFMRTIBLNN-CNSTRINDCMNTDMTALPLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9527654
• MDR Text Key: 173229791
• Report Number: 1020279-2019-04606
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 03596010627339
• UDI-Public: 03596010627339
• 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
• Report Date: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71422344
• Device Catalogue Number: 71422344
• Device Lot Number: 16JM02133
• Date Manufacturer Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention