MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN JOURNEY BCS / JOURNEY II BCS KNEE INSERT; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number UNKN01200310

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

Patient Problem Unspecified Infection (1930)

Event Date 08/13/2023

Event Type  Injury  

Manufacturer Narrative

Internal reference number: (b)(4).H10: smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.

Event Description

It was reported that, after a tka, patient came to or with an infection.A 11mm left journey ii bcs poly had to be replaced.Patient's current health status is unknown.

Manufacturer Narrative

H3, h6.The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, as of the date of this medical investigation, the requested clinical documentation has not been provided; consequently, there were no clinical factors found which would have contributed to the reported infection.According to the report, a 11mm left journey ii bcs insert had to be replaced.However, per the report, the patient's current health status is unknown, therefore, the impact to the patient beyond that which has already been reported cannot be confirmed nor concluded.Should any additional relevant medical information be provided, this case would be re-assessed.Device specific identifiers were not provided.Therefore, an evaluation of the manufacturing records, complaint history review and sterilization records review could not be performed.A review of the risk management file revealed this failure mode was previously identified.A review of previous actions concluded that there is a higher than expected risk of revision surgery when the patella is unresurfaced at the index surgery.Patella resurfacing is an intraoperative discretionary decision of the surgeon, and this clinical decision may mitigate risk for individual patients.Actions were taken to update the instructions for use document and surgical technique to include statements informing users that outcome data reported in some registries suggest that resurfacing the patella during primary total knee arthroplasty should be considered since it may decrease the rate of revision, provided the patient¿s anatomical and clinical conditions allow.However, it is unknown if the patella was resurfaced during the index surgery; therefore, there is not enough information to relate this event with the prior actions found.Additionally, the instructions for use documents for knee systems revealed that acute post-surgical wound infection has been identified in the possible adverse effects.Active, local infection or previous intra-articular infections are identified in contraindications for total knee replacement.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include loss of sterility during procedure, post-operative healing issue, injury, patient condition and/or medical history.Based on this investigation, the need for corrective action is not indicated.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: UNKN JOURNEY BCS / JOURNEY II BCS KNEE INSERT
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• 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: 17680471
• MDR Text Key: 322603949
• Report Number: 1020279-2023-01716
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKN01200310
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention