MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY II UK TIB INSRT MED SZ 3-4 9MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 74026159

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

Event Date 08/22/2023

Event Type  Injury  

Event Description

It was reported that, after tka surgery had been performed on (b)(6) 2023, the patient experienced pain, swelling and suspected infection.This adverse event was treated by a revision surgery on (b)(6) 2023, in which the patient experienced debridement and the journey ii uk tib insrt med sz 3-4 9mm was exchanged.Current health status of the patient is unknown.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation stated that, as of the date of this medical investigation, the requested clinical documentation had not been provided for evaluation.It was noted within the attachments that further information is not available.Therefore, there were no clinical factors found which would have contributed to the reported event.The impact to the patient beyond the reported pain, swelling, suspected infection, and debridement/revision surgery cannot be determined.No further clinical assessment can be rendered at this time.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the devices did not reveal similar events for the listed devices.A review of the instructions for use documents for unicompartimental knee systems revealed that acute post-surgical wound infection could occur as well as active, local infection or previous intra-articular infections.This has been identified as an adverse reaction and a contraindication for unicompartimental knee replacement.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 no prior actions related to these products and event.A review of the sterilization records revealed the batches were sterilized within normal parameters.At this time, we have no reason to suspect that the products 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 devices 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: JOURNEY II UK TIB INSRT MED SZ 3-4 9MM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-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: 17781799
• MDR Text Key: 323846176
• Report Number: 1020279-2023-01801
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00885556677070
• UDI-Public: 00885556677070
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K190085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74026159
• Device Lot Number: 22AAP0090T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/19/2022
• 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
• Treatment: 74026024/23AM09034/JOURNEY II UK OX FEM SZ 4 LM/RL; 74026714/22AAP0052F/JOURNEY II UK MED TIB BASE SZ
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female