MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4 LT 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74027241
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	02/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: case (b)(4).
Event or Problem Description
It was reported that after a tka surgery for left knee was performed on (b)(6) 2024, the patient experienced an infection.This adverse event was resolved by revision surgery on (b)(6) 2024, during which one (1) jrny ii bcs xlpe art isrt sz 3-4 lt 9mm was exchanged, and a new journey ii bcs insert was implanted.The femoral component, tibial baseplate, and patella component remained.The current health status of the patient is unknown.
Additional Manufacturer Narrative
The explanted insert was not returned for evaluation and, given the nature of the alleged incident, the femoral component, tibial baseplate and patella component could not be returned; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, based on the limited information provided, the patient was revised due to the reported infection, however, the definitive root cause of the reported infection cannot be determined.Post-operative infections are a known occurrence after surgery.Therefore, the reported infection three-week post-left total knee arthroplasty was likely related to the procedure and not a malperformance of the smith and nephew device.Although, a hematogenous spread cannot be ruled out.The impact to the patient beyond the reported infection and subsequent revision cannot be determined since the status of the patient is unknown.A review of the manufacturing records could not be performed for the insert, since the device history record for this production order was not available.This issue was escalated through our quality process.For the rest of the devices, the 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 revealed a similar event for the tibial baseplate and similar events for the femoral and patella components over the previous 12 months, but no similar events for the batches based on the historical data.For the insert, a similar event was revealed for the listed batch.This failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for knee systems revealed that acute post-surgical wound infection has been identified in possible adverse effects.Active, local infection or previous intra-articular infections are identified in contraindications for total knee replacement.A review of the risk management files 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 this products and event.A review of the sterilization records revealed the batches were sterilized within normal parameters.At this time, we have no evidence to conclude 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 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: JRNY II BCS XLPE ART ISRT SZ 3-4 LT 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: 18941216
• Report Number: 1020279-2024-00576
• Device Sequence Number: 11505594
• Product Code: JWH
• UDI-Device Identifier: 00885556177617
• UDI-Public: 00885556177617
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 74027241
• Device Lot Number: 23CM09649
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/29/2024
• Supplement Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71932636 / LOT# 23KM13298; 74022126 / LOT# 23AM03021; 74022224 / LOT# 23JM16595
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown