MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM OX NP LT SZ 3; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER

Model Number	74021163
Medical Device Problem Codes	Material Erosion (1214); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Damage to Ligament(s) (1952); Loss of Range of Motion (2032)
Date of Event	09/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after tka procedure on (b)(6) 2020, the patient got pcl malfunction due to falling and felt impingement between femur and tibia.In addition, during x-rays it was confirmed the jrny ii cr fem ox np lt sz 3 and jrny ii xr baseplate sz 2 lt were wear.A revision surgery will be performed but the date is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: given the nature of the event, the device was not returned for evaluation and, but clinical data analysis confirmed the reported pcl malfunction, but not wear of the components.The clinical/medical investigation concluded that the provided left knee imaging labeled (b)(6) 2022 appears to show flecks of radiodensities concentrated anteriorly within the joint space; however, do not confirm wear of a particular component.The imaging labeled as ¿aging 2020, 2021, 2022¿ and the unidentified flexion images do show the reported ¿pcl malfunction¿ following the fall.The current patient health status remains unknown, and it was communicated that no further information regarding the planned revision is available at this time.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.Reportedly, the fall was the root cause of the ¿pcl malfunction¿ and impingement between the femur and tibia with component wear.No further clinical factors have been concluded to have contributed to the reported event.The assessed patient impact includes the reported impingement and ¿pcl malfunction¿ following the fall, along with the anteriorly concentrated radiodensities within the articulating joint space.Further patient impact cannot be determined.No further medical assessment can be rendered at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 listed device.A review of the instructions for use documents for knee systems reveal in possible adverse effects that 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 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 include friction, joint tightness and/or traumatic injury.The contribution of the device to the reported incident could be corroborated as a revision surgery will be required to treat this event.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.
Additional Manufacturer Narrative
H6: medical device problem code: corrected.

• Brand Name: JRNY II CR FEM OX NP LT SZ 3
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER
• 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: 15535484
• Report Number: 1020279-2022-04276
• Device Sequence Number: 8132978
• Product Code: JWH
• UDI-Device Identifier: 00885556422809
• UDI-Public: 00885556422809
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 74021163
• Device Catalogue Number: 74021163
• Device Lot Number: 20BM12067
• 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: 09/12/2022
• Supplement Date Received by Manufacturer: 10/28/2022; 10/28/2022
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 10/31/2022; 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown