MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY DCF AP FEM CUT BLK 4; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 74012414

Device Problem Failure to Disinfect (1175)

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during an investigation study of journey ii and legion implants conducted by hospital/doctor and not sponsored by s&n, 14 of 57 surgeries present a complaint (one surgery per patient).The complications were swelling, pain and infection.13 of the complaints were from journey ii patients and 1 of the complaints was from a legion patient.The hospital is blaming the sterilization process of cutting blocks.No further information is available at the moment.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.The clinical/medical team concluded, the clinical/medical task was re-opened due to receipt of device for product evaluation (01/13/2021) which will be performed and reported independent of the medical investigation.No further clinical documentation has been provided; therefore, no change to the previous medical assessment is warranted.A visual inspection confirmed the journey dcf ap fem cut blk 3 shows nicks and scratches.The device shows significant signs of wear/usage.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.A review of the risk management file revealed this failure mode was previously identified.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 is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.For cleaning procedures please refer to smith and nephew¿s recommended cleaning methods given in our cleaning and sterilization brochure-¿instructions for care, maintenance, cleaning and sterilization of smith and nephew orthopedic devices¿.The document is available from customer service or via the smith and nephew website, which suggests using a surgical scrub brush to remove visible debris.Product was sterilized according to sterilization release documentation from quality control.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: JOURNEY DCF AP FEM CUT BLK 4
• 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: 11276956
• MDR Text Key: 230211543
• Report Number: 1020279-2021-00933
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010556660
• UDI-Public: 03596010556660
• 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: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 74012414
• Device Catalogue Number: 74012414
• Device Lot Number: 19AM12946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 02/18/2021
• Supplement Dates FDA Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention