MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II XR INS XLPE MED 5-6 RT 8MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74023750
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint Laxity (4526)
Date of Event	01/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a clinical study, after a tka had been performed on (b)(6) 2018, the patient experienced right knee severe pain and instability.A revision surgery was performed on (b)(6) 2021 to address this adverse event.The explanted devices were: jrny ii xr ins xlpe med 5-6 rt 8mm, jrny ii cr fem cocr np rt sz 5, jrny ii xr baseplate sz 5 rt and gii oval resurfacing pat 32mm.Patient's current health status is unknown.
Additional Manufacturer Narrative
H6:health effect - clinical code.Section h3, h6: the devices were not returned for evaluation; therefore, devices analysis could not be performed.The clinical/medical investigation concluded that, per complaint details, the study-patient required a right revision due to severe pain and instability approximately 3 years post implantation.Per correspondence, the start date of the adverse event was (b)(6) 2021; however, the electronic case report form of the adverse event documented the same start and stop date of (b)(6) 2021 with a patellar component revision resolving the adverse event.The unanticipated serious adverse event was documented as severe, possibly related to the study device and/or the study procedure with a recovered/resolved outcome post surgery (revision) for the ¿failed patella component¿.It is noted that the participation in the study was discontinued due to the reported event.Based on the information provided as of the date of this medical investigation, a definitive clinical root cause of the reported ¿failed patella component¿ cannot be concluded.The patient impact beyond the reported symptoms and subsequent revision with discontinued study participation could not be determined.No further medical assessment could be rendered at this time.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 numbers over the past 12 months and for the batch numbers based on historical data of the devices did not reveal similar events for the insert, femoral component and tibial base plate.A review of complaint history for the previous 12 months did not reveal similar events for the patella.A review of the instructions for use documents for knee systems revealed that dislocation, subluxation, excessive rotation, flexion contracture, decreased range of motion, lengthening or shortening of the leg, looseness of components, unusual stress concentrations, and extraneous bone can result from trauma, improper implant selection, improper implant positioning, improper fixation, and/or migration of the components.Muscle and fibrous tissue laxity can also contribute to these conditions, this has been identified as possible adverse effects.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 reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, joint laxity or patient condition.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.H6: health effect - impact code.

• Brand Name: JRNY II XR INS XLPE MED 5-6 RT 8MM
• 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: 16728295
• Report Number: 1020279-2023-00798
• Device Sequence Number: 20482407
• Product Code: JWH
• UDI-Device Identifier: 00885556613108
• UDI-Public: 00885556613108
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K152726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2023

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 Expiration Date: 02/23/2026
• Device Model Number: 74023750
• Device Catalogue Number: 74023750
• Device Lot Number: 16BM19440
• 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: 03/17/2023
• Supplement Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2016
• 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: 71421032 / UNKNOWN; 74021255 / B1710850; 74022295 / 16KSL0010A
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male