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

Catalog Number	74027231
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	10/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a tka surgery was performed on (b)(6) 2023, the patient experienced infection.A revision surgery and debridement were performed on the 10-oct-2023 to treat this adverse event in which a jrny ii bcs xlpe art isrt sz 3-4-rt 9mm was exchanged while a jrny ii bcs femoral oxin rt sz 6, journey tibia base np rt sz 4 and a gen ii 7.5mm resur pat 29mm remained.In addition, the surgeon does not believe that the product is at fault.The current health status of the patient remains unknown.
Additional Manufacturer Narrative
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 is noted via e-mail correspondence that further information is not available.Therefore, there were no clinical factors identified with would have contributed to the reported infection and subsequent revision surgery.It has been reported that the surgeon does not believe the product is at fault.The impact to the patient beyond the revision surgery cannot be determined.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 number of the articular insert over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of complaint history revealed a similar event for the femoral component, tibial baseplate and resurfacing patella over the previous 12 months, but no similar events for the batches based on the historical data, 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 as a possible adverse effect.Additionally, 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 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: JRNY II BCS XLPE ART ISRT SZ 3-4-RT 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: 18074090
• Report Number: 1020279-2023-02145
• Device Sequence Number: 12660956
• Product Code: JWH
• UDI-Device Identifier: 00885556179017
• UDI-Public: 00885556179017
• 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: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2023

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: 74027231
• Device Lot Number: 23AM11178
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2023
• Supplement Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2023
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN: 71932635 / LOT: 23DM13946; PN: 74022116 / LOT: 22LM14151; PN: 74022214 / LOT: 23BM15422
• Patient Sex: Male