MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II C/R FEM SIZE 4 LEFT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	71420006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Arthralgia (2355)
Date of Event	01/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, after a tka revision surgery performed on (b)(6) 2019 to exchange the patellar and polyethylene insert components, the patient continued to experience chronic pain, weakness, limitations with mobility and decreased rom.X-ray evaluation showed implants in good alignment with no evidence of loosening, malalignment, or problem.Although medicated with tylenol and meloxicam and after completing a physiotherapy plan without success, the surgeon responsible for the revision surgery on (b)(6) 2019 recommended a third intervention of the left knee, but the patient has declined it.The patient¿s current health status is unknown.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation.The pictures provided were reviewed and could not confirm any misalignment or loosening that can contribute to the adverse effects experienced by the patient.The clinical/medical investigation concluded that, based on the documentation provided, the root cause of the reported multiple post-revision symptoms could not be definitively concluded; however, the ¿severe tenderness along the it band was reportedly due to itb tendinitis.Additionally, revision findings of ¿large amount scar removed from medial & lateral gutters¿ increase suspicion for recurrent scar formation (a known occurrence post-tka) which may contribute to the reported pain/aching/stiffness with limited rom and mobility.Of note, the off-label implantation of a mixed manufacturer construct could not be ruled out as another potential contributing factor to the reported symptoms.The patient impact beyond the reported chronic symptoms, prescribed pt and medications could not be determined.The patient reportedly declined further surgical intervention in lieu for cbd oil.No further medical assessment can be rendered at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, 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 decreased range of motion and pain has been identified as a possible adverse effects.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.Possible causes could include but not limited to traumatic injury, joint tightness, material in use, patient reaction, alignment, fit/size of device used or wear.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.

• Brand Name: GNS II C/R FEM SIZE 4 LEFT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• 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: 14466765
• Report Number: 1020279-2022-02491
• Device Sequence Number: 4569403
• Product Code: JWH
• UDI-Device Identifier: 03596010205445
• UDI-Public: 03596010205445
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2022

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 Expiration Date: 02/09/2024
• Device Model Number: 71420006
• Device Catalogue Number: 71420006
• Device Lot Number: 14BM07513
• 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: 04/27/2022
• Supplement Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 05/21/2022
• Supplement Report FDA Received Date: 06/24/2022
• Date Device Manufactured: 02/11/2014
• 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: 71420164
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female