MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY DCF AP FEM CUT BLK 3; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 74012413

Device Problem Break (1069)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the journey dcf ap fem cut blk 3 broke.Further information is unknown at this time.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.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 complaint history based on the historical data revealed similar events for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are prior actions for the same device, but they cannot be linked to the complaint device.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.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.The contribution of the device to the reported event could not be corroborated.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.Case-2022-00090291-1.

Manufacturer Narrative

Was updated with the new information received.Internal complaint reference number: case (b)(4) was corrected according to the new information received.

Event Description

It was reported that the journey dcf ap fem cut blk 3 broke.This was noticed after surgery, therefore no patient was involved.

Event Description

It was reported that the journey dcf ap fem cut blk 3 broke.This was noticed after surgery, therefore no patient was involved.On visual inspection it was found that the device was found to be disassembled, rendering the device inoperative.The device shows signs of extensive use.

Manufacturer Narrative

Upon visual inspection of the returned device by the manufacturer, it was identified that this event should be re-evaluated for mdr reporting.The new information states that the device was not broken but was disassembled, rendering the device inoperative, and showed signs of extensive use.Therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event since it is a use error that did not lead to a device-related death or serious injury.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: JOURNEY DCF AP FEM CUT BLK 3
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13540308
• MDR Text Key: 285735028
• Report Number: 1020279-2022-00722
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010556653
• UDI-Public: 03596010556653
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 74012413
• Device Catalogue Number: 74012413
• Device Lot Number: 17AM16313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1