MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY DCF AP FEM CUT BLK 7; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 74012417

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/21/2020

Event Type  Injury  

Event Description

It was reported that during procedure the size 7 journey ii cut block shift mechanism was not working properly.When set to 2mma, the block was shifted posterior, leading to a notched femur.Procedure was successfully completed with the same device.No surgical delays reported.

Manufacturer Narrative

Internal complaint reference (b)(4).The device, used in treatment, was returned for evaluation.Our investigation included a visual inspection which confirmed the failure of the device.This issue was previously identified and is a result of both design and manufacturing processes.A design/ process change was previously implemented to prevent reoccurrence of this failure mode going forward.The device for this complaint was manufactured prior to those changes.The device was manufactured in 2008.This device exhibits signs of extreme wear and use.A medical investigation was conducted and this case reports the femoral cutting block shift mechanism was not working properly, and the block shifted posterior, leading to a notched femur.Per complaint details, the procedure was completed successfully without delay, using the same device.No additional patient injury was reported.Therefore, no further clinical assessment is warranted at this time.A review of complaint history on the listed part revealed no prior complaint for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of risk management files found that the reported failure was documented appropriately.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.) corrected information was provided on b1 and h1.

• Brand Name: JOURNEY DCF AP FEM CUT BLK 7
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10841655
• MDR Text Key: 216306093
• Report Number: 1020279-2020-06464
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010556691
• UDI-Public: 03596010556691
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2020
• Device Model Number: 74012417
• Device Catalogue Number: 74012417
• Device Lot Number: 08JM15742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Date Manufacturer Received: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other