MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY UNI TIBIAL BASE RM/LL SZ 2; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71422432
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Arthritis (1723); Inadequate Osseointegration (2646)
Date of Event	10/26/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a right tka performed on (b)(6) 2019 due to osteoarthritis, the patient experienced aseptic loosening of the tibial component and progression of the arthritis.This was addressed via revision surgery on (b)(6) 2020 were all components where exchange.This information was provided by the national joint registry of the united kingdom, as part of a retrospective data collection of patients who underwent a revision surgery of journey uni prothesis.As such, no further information will be available.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Given the nature of the alleged incident, the device, could not be returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, a right revision was performed approximately 16 months post uka due to aseptic loosening of the tibial component and progressive arthritis.As of the date of this medical investigation, the requested clinical documentation has not been received as the information was provided by the national joint registry of the united kingdom as part of a retrospective data collection, and reportedly, no further information will be available.Without the requested medical documentation, possible clinical factors which could have contributed to the reported event could not be definitively concluded.The patient outcome beyond that which was reported could not be determined.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.A review of the instructions for use documents for knee systems revealed that loosening has been identified as a possible adverse effect.According to the intraoperative section, failure to use the optimum size component could be one of the probable causes of loosening.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.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 have been identified as abnormal motion over time, bone degeneration, size selection, lack of ingrowth, osteolysis and/or traumatic injury.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 device 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.Internal complaint reference number: (b)(4).

• Brand Name: JRNY UNI TIBIAL BASE RM/LL SZ 2
• Common Device Name: 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: 15358790
• Report Number: 1020279-2022-03974
• Device Sequence Number: 5889059
• Product Code: HSX
• UDI-Device Identifier: 00885556088197
• UDI-Public: 00885556088197
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: 12DM12553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2022

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: 71422432
• Device Catalogue Number: 71422432
• 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: 08/17/2022
• Supplement Date Received by Manufacturer: 09/30/2022
• Initial Report FDA Received Date: 09/05/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: JOURNEY UNI TIBINRT S1-2RM/LL8MM, LOT#:12DM12553.; JUNI OX FB FEM SZ 2 RM LL.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Unknown