MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II ISRT XLPE DD RT SZ 7-8 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74025771
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, while performing a tka revision surgery on (b)(6) 2022, it was found that the inner peel pack of the jrny ii isrt xlpe dd rt sz 7 8 9mm was opened.Since there were no more implants available, surgeon had to close the knee, after a significant delay, with a trial in and rescheduled the case for the next day.The following day, on (b)(6) 2022, a revision surgery was performed in order to implant a new sterile insert.The current health status of patient is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Section h3, h6: the package was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, while performing a tka revision surgery on (b)(6) 2022, it was found that the inner peel packs of two (2) jrny ii isrt xlpe dd rt sz 7 8 9mm were opened.Since there were no more implants available, surgeon had to close the knee, after a significant delay, with a trial in and rescheduled the case for the next day.The following day, on (b)(6) 2022, a revision surgery was performed in order to implant a new sterile insert.As of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.The patient's current condition is unknown, and the patient impact could not be determined based on the limited information provided.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch 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 reveals that it provides complete guidelines of indications, contraindications, warnings and precautions and possible adverse effects that may occur preoperative, during surgery or post operative.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 this product and event.This issue was evaluated through our internal quality process, and an enhancement will be made to include a polybag inside the packaging.According to the packaging sequence the inner and outer pouch should be sealed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include damage during shipping or handling.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the package 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 ISRT XLPE DD RT SZ 7-8 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: 15466885
• Report Number: 1020279-2022-04159
• Device Sequence Number: 20585779
• Product Code: JWH
• UDI-Device Identifier: 00885556098813
• UDI-Public: 00885556098813
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K113482
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/24/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 74025771
• Device Catalogue Number: 74025771
• Device Lot Number: 19HM05416
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2022
• Supplement Date Received by Manufacturer: 08/31/2022; 11/18/2022
• Initial Report FDA Received Date: 09/22/2022
• Supplement Report FDA Received Date: 10/07/2022; 11/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2019
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown