MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM OX NP RT SZ 3; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74021153
Medical Device Problem Codes	Biocompatibility (2886); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Damage to Ligament(s) (1952); Metal Related Pathology (4530)
Date of Event	09/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference number:(b)(4).H10: smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.
Event or Problem Description
It was reported that, after a tka surgery had been performed on (b)(6) 2021.A revision surgery was performed on (b)(6) 2023 due to a feeling of wrongness a month prior.During the revision surgery, it was found that the acl and pcl were torn.Additionally, it was found that the insert was worn and that the femoral component was hitting the tibial baseplate, which caused metallosis.All implanted products were exchanged to legion.Patient's current health status is unknow.
Additional Manufacturer Narrative
Section h3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation stated that the current patient health status and the requested medical documentation are not available.In the absence of the requested information, clinical factors which could have contributed to the reported event could not be definitively concluded.The patient impact beyond the reported onset of symptoms and revision with intraoperative findings cannot be determined.No further medical assessment can 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 listed devices.A review of the instructions for use documents for knee systems revealed that although rare, metal sensitivity or allergic reactions in patients following joint replacement have been reported.Implantation of foreign material in tissues can result in histological reactions involving macrophages and fibroblasts.Additionally, wear of the polyethylene articulating surfaces of knee replacement components has been reported following total knee replacement.Higher rates of wear may be initiated by particles of cement, metal, or other debris which can cause abrasion of the articulating surfaces.Higher rates of wear may shorten the useful life of the prosthesis and lead to early revision surgery to replace the worn prosthetic components.These have been identified as possible adverse effects.A review of the risk management files revealed these failure modes were 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 products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include irregular implant interaction, abnormal motion over time 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.
Additional Manufacturer Narrative
The associated devices were returned and evaluated.The retrieved devices were examined using visual and macroscopic/microscopic methods.Visual examination of the retrieved items showed damage to the medial condyle of the femoral, damage to the medial side of the outer rail on the tibial baseplate, and delamination damage to the articular surface of the medial insert.The femoral and baseplate components revealed multiple scratches and signs of wear.Macroscopic/microscopic examination of the retrieved items showed no damage observed on the leading anterior edge of the medial insert, wear and discoloration on the articular surface of the lateral insert, and damage to the leading anterior edge of the lateral insert.No damage was observed on the leading anterior edge of the medial insert.No additional unexpected visual features noted.No evidence of deviation in processing or material was found for the retrieved item.No definitive conclusions as to the cause of these issues can be determined.The clinical/medical investigation concluded that, in the absence of the requested information, clinical factors which could have contributed to the reported event could not be definitively concluded.The patient impact beyond the reported onset of symptoms and revision with intraoperative findings cannot be determined.No further medical assessment can 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 device did not reveal similar events for the listed devices.A review of the instructions for use documents for knee systems revealed in the possible adverse effects that, although rare, metal sensitivity or allergic reactions in patients following joint replacement have been reported.Implantation of foreign material in tissues can result in histological reactions involving macrophages and fibroblasts.Additionally, wear of the polyethylene articulating surfaces of knee replacement components has been reported following total knee replacement.Higher rates of wear may be initiated by particles of cement, metal, or other debris which can cause abrasion of the articulating surfaces.Higher rates of wear may shorten the useful life of the prosthesis and lead to early revision surgery to replace the worn prosthetic components.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 this 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 irregular implant interaction, wear, abnormal motion over time, friction, 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: JRNY II CR FEM OX NP RT SZ 3
• 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: 17951285
• Report Number: 1020279-2023-01958
• Device Sequence Number: 6715554
• Product Code: JWH
• UDI-Device Identifier: 00885556422861
• UDI-Public: 00885556422861
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/23/2024

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: 74021153
• Device Lot Number: 21GM12633
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2023
• Supplement Date Received by Manufacturer: 11/20/2023; 02/21/2024
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 11/20/2023; 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2021
• 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: 74022291/JRNY II XR BASEPLATE SZ 1 RT; 74023711/JRNY II XR INS XLPE MED 1-2 RT 9MM; JRNY II XR INS XLPE LAT 1-2 RT 9MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female