MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 5-6 RT 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74027253
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Arthralgia (2355); Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: case (b)(4).
Event or Problem Description
It was reported that, after a left knee replacement with journey ii bcs system had been performed on an unspecified date, the patient has stated that he cannot live with the pain that it causes every time he bends the knee or walks.The patient has also claimed that (i) the surgeon who implanted the system did not address the reactions he experienced on the knee at first, so he consulted another surgeon for a second opinion; (ii) the new surgeon indicated that the knee requires a revision surgery, which will be performed in may; (iii) something not right there and nobody seems to know how to fix it, although he believes that the problem is the insert because his research showed that s+n has recalled similar parts.The event is ongoing.
Additional Manufacturer Narrative
H3, h6: given the nature of the alleged incident, the devices could not be returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that the provided x-ray appears to show bilateral total knee arthroplasties with scattered heterotopic bone formation (predominantly around the tibial baseplates) with possible bilateral radiolucency at inferolateral tibial baseplates and the left insert appears thicker than the right.Hardware (3 screws) noted in right lateral tibia as well as radiolucency under the lateral baseplate.There is ossification in both the medial and lateral soft tissue bilaterally.Patient provided an undated/unidentified phone screenshot of (b)(6) 2023 assessment which indicates a bilateral inflammatory reaction with suspected mechanical loosening as the cause for pain and swelling without any concern for infection.Based on the documentation provided, the patient¿s right knee symptoms are likely due to the suspected mechanical loosening.The length of time between symptom onset and proposed intervention likely contributes to the severity of the symptoms.Based on the patient¿s contralateral total knee arthroplasty history, possible ligament laxity and progression of disease cannot be ruled out as potential contributing factors, as well.The patient is to undergo a revision in may 2024; therefore, the event is ongoing and unresolved.The patient impact includes the reported suspected mechanical loosening with ongoing pain and swelling with an anticipated right knee revision.No further impact can be determined 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 device did not reveal similar events for the listed devices.A review of the risk management files revealed this failure mode was previously identified.A review of previous actions concluded that there is a higher than expected risk of revision surgery when the patella is unresurfaced at the index surgery.Patella resurfacing is an intraoperative discretionary decision of the surgeon, and this clinical decision may mitigate risk for individual patients.Actions were taken to update the instructions for use document and surgical technique to include statements informing users that outcome data reported in some registries suggest that resurfacing the patella during primary total knee arthroplasty should be considered since it may decrease the rate of revision, provided the patient¿s anatomical and clinical conditions allow.The review of the instructions for use documents for knee systems also revealed in the warnings and precautions section states that correct selection of the implant is extremely important.The appropriate type and size should be selected for patients with consideration of anatomical and biomechanical factors such as patient age and activity levels, weight, bone and muscle conditions, etc.Failure to use the optimum size component may result in loosening, bending, cracking, or fracture of the component and/or bone.Moreover, the possible adverse effects section revealed that unusual stress concentrations 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.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 possible ligament laxity, progression of disease, abnormal motion over time, bone degeneration, inadequate integration between the cement and bone/implant, osteolysis and/or traumatic injury.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.
Additional Manufacturer Narrative
Additional information: g2 (medwatch report reference number added), g3/g4 (pma/510(k)number) corrected data: b5, e4 (initial reporter also sent report to fda?), g2, h6 (health effect - clinical code).
Event or Problem Description
It was reported that, after a left knee replacement with journey ii bcs system had been performed on an unspecified date, the patient has stated that he cannot live with the pain that it causes every time he bends the knee or walks.The patient has also claimed that (i) the surgeon who implanted the system did not address the reactions he experienced on the knee at first, so he consulted another surgeon for a second opinion; (ii) the new surgeon indicated that the knee requires a revision surgery, which will be performed in (b)(6) 2024; (iii) something not right there and nobody seems to know how to fix it, although he believes that the problem is the insert because his research showed that s+n has recalled similar parts.The event is ongoing.
Additional Manufacturer Narrative
H10: additional information in b5.H11.Corrected information in d1, d2, d4, d10, g4, and h4.
Event or Problem Description
It was reported that, after a left knee replacement with journey ii bcs system had been performed on an unspecified date, the patient has stated that he cannot live with the pain that it causes every time he bends the knee or walks.The patient has also claimed that (i) the surgeon who implanted the system did not address the reactions he experienced on the knee at first, so he consulted another surgeon for a second opinion; (ii) the new surgeon indicated that the knee requires a revision surgery.(iii) something not right there and nobody seems to know how to fix it, although he believes that the problem is the insert because his research showed that s+n has recalled similar parts.The revision surgery of the left knee was performed on (b)(6) 2024.
Additional Manufacturer Narrative
H6, h10: the associated insert was returned and evaluated.A visual inspection of the returned insert reveals gouges, scratches and discoloration on the device.The device shows signs of wear and use.A lab analysis was performed and revealed that the retrieved journey ii bcs insert was intact.Visual examination showed extraction marks near the slot on the lock detail of the insert, scratches and deformation on non-articulating superior surfaces of the insert, and burnishing wear and discoloration at the base of the post.Extraction damage can be created by the removal instrumentation used during the extraction of the implant, which is likely the cause of the damage observed.Burnishing wear and discoloration were found at the base of the post.The scratches, deformation, burnishing wear, and discoloration are not unexpected findings for an insert that has been implanted for over six years and are likely the result of normal articulation of the implanted components.Macroscopic/microscopic examination showed scratches and wear on the articular surface and deformation of the leading edges of the anterior lock detail.The scratches and wear on the articular surface are likely the result of normal articulation of the implanted components.Deformation to the anterior lock detail is consistent with the locking of the insert to the lock detail of the mating tibial baseplate and likely indicates that the insert was locked into the tibial baseplate.No evidence of deviation in processing or material was found for the retrieved item.Destructive testing was not performed during this examination.The rest of the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that the provided x-ray appears to show bilateral total knee arthroplasties with scattered heterotopic bone formation (predominantly around the tibial baseplates) with possible bilateral radiolucency at inferolateral tibial baseplates and the left insert appears thicker than the right.Hardware (3 screws) noted in right lateral tibia as well as radiolucency under the lateral baseplate.There is ossification in both the medial and lateral soft tissue bilaterally.Patient provided an infectious disease follow-up note of (b)(6) 2023: assessment/plan which indicates a bilateral inflammatory reaction with suspected mechanical loosening of hardware as the cause for pain and swelling without any concern for infection.Based on the documentation provided, the patient¿s right knee symptoms and subsequent revision are likely due to the suspected mechanical loosening.The length of time between symptom onset and proposed intervention likely contributes to the severity of the symptoms.A component malperformance is not supported in the documentation provided.Based on the patient¿s contralateral total knee arthroplasty history, possible ligament laxity and progression of disease cannot be ruled out as potential contributing factors, as well.The patient impact includes the reported symptoms with subsequent revision, which was scheduled for (b)(6) 2024 due to suspected mechanical loosening with ongoing pain and swelling.No further impact can be determined 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.For the insert, a review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events.For the femoral component and tibial baseplate, a review of complaint history revealed a similar event for the listed devices 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 risk management files revealed this failure mode was previously identified.A review of previous actions concluded that there is a higher than expected risk of revision surgery when the patella is unresurfaced at the index surgery.Patella resurfacing is an intraoperative discretionary decision of the surgeon, and this clinical decision may mitigate risk for individual patients.Actions were taken to update the instructions for use document and surgical technique to include statements informing users that outcome data reported in some registries suggest that resurfacing the patella during primary total knee arthroplasty should be considered since it may decrease the rate of revision, provided the patient¿s anatomical and clinical conditions allow.The review of the instructions for use documents for knee systems also revealed in the warnings and precautions section states that correct selection of the implant is extremely important.The appropriate type and size should be selected for patients with consideration of anatomical and biomechanical factors such as patient age and activity levels, weight, bone and muscle conditions, etc.Failure to use the optimum size component may result in loosening, bending, cracking, or fracture of the component and/or bone.Moreover, the possible adverse effects section revealed that unusual stress concentrations 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.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 possible ligament laxity, progression of disease, abnormal motion over time, bone degeneration, inadequate integration between the cement and bone/implant, osteolysis and/or traumatic injury.Based on this investigation, the need for corrective action is not indicated.Should a 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.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 5-6 RT 11MM
• 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: 18927164
• Report Number: 1020279-2024-00561
• Device Sequence Number: 14597265
• Product Code: JWH
• UDI-Device Identifier: 00885556179468
• UDI-Public: 885556179468
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/02/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 74027253
• Device Lot Number: 17DM08108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/26/2024; 04/03/2024; 04/09/2024; 09/12/2024; 09/26/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 04/01/2024; 04/05/2024; 04/11/2024; 09/12/2024; 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2017
• 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: 74022116 / LOT NUMBER: 17KM12718; 74022216 / LOT NUMBER: 18AM14158; PN: 74022116 / LOT: 17KM12718; PN: 74027253 / LOT: 17DM08108
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Sex: Male