MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN JOURNEY / JOURNEY II KNEE IMPL; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	UNKN01200301
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference number: case (b)(4).
Event or Problem Description
It was reported that, after a right tka surgery had been performed on (b)(6) 2014 due to osteoarthritis, the patient has experienced ongoing pain a swelling.This adverse event has been treated by multiple approaches, including a knee aspiration and steroid injection on 31-jan-2018.Bone scans confirmed large joint effusion and patellar maltracking, for which, on (b)(6) 2018, bilateral knee release was performed to address this kneecap positioning problem.A second knee aspiration was performed on (b)(6) 2019.Patient's pain and swelling is still ongoing.
Additional Manufacturer Narrative
Given the nature of the alleged incident, the devices, could not be returned for evaluation.However the unsatisfactory experience can be confirmed.The clinical/medical investigation concluded that, based on the limited information provided, the definitive clinical root cause of the reported ongoing pain and swelling could not be determined.The provided right knee x-rays do not indicate a root cause.However, no x-rays images or reports were not provided from 2018 thru 2024, for evaluation or comparison.We cannot rule out a possible trauma, the patient¿s age, history of osteoarthritis, neuropathy, gout, bone quality, alcohol usage, activity level as contributory factors.Since these adverse events are still ongoing, no further clinical/medical assessment can be rendered at this time.The impact of the patient beyond that which has already reported cannot be determined if the reported adverse events have not been resolved.Devices´ batch numbers were not provided, thus, an evaluation of the manufacturing records could not be performed.For the patella a review of complaint history of the previous 12 months revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.For the rest of the devices, a review of complaint history for the previous 12 months did not reveal similar events for the listed devices.A review of the instructions for use documents for knee systems revealed that postoperative patient care and directions and warnings to patients by physicians are extremely important.Protected weight bearing with external support is recommended for a period of time to allow healing.Normal daily activity may be resumed at the physician¿s direction.Also, warnings and precautions states that the patient should be warned of surgical risks, and made aware of possible adverse effects.The patient should be warned that that the implant can become damaged as a result of strenuous activity or trauma.Besides, possible adverse effects section states that temporary or permanent nerve damage can result in pain or numbness of the affected limb.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.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, joint tightness or patient condition.Based on this investigation, the need for corrective action is not indicated.Should 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 / JOURNEY II KNEE IMPL
• 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: 19121440
• Report Number: 1020279-2024-00757
• Device Sequence Number: 12672878
• Product Code: JWH
• UDI-Device Identifier: 00885556170069
• UDI-Public: 00885556170069
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2024

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
• Device Catalogue Number: UNKN01200301
• Device Lot Number: UNKNOWN
• 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: 03/18/2024
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GNS II RESURF PAT 35MM / 71420578; JOURNEY TIBIA BASE NP RT SZ 8 / 74022218; JRNY II BCS XLPE ART ISRT SZ 7-8 RT 9MM / 74027271
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 95 KG