MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION PS OXIN FEM SZ4 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71421214
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060)
Date of Event	01/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, on (b)(6) 2022, a left tka surgery was performed with legion and genesis ii implants.On (b)(6) 2023 the patient had to undergo a closed knee manipulation procedure, due to poor recovery, excessive scar tissue, chronic pain and inflammation, and mobility issues.Since the tka, the patient has also received continuous physical therapy, but no procedure has resolved their symptoms.
Additional Manufacturer Narrative
H3, h6: given the nature of the alleged incident, the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, per complaint details, a closed manipulation was performed approximately 6 weeks post implantation due to poor recovery, excessive scar tissue, chronic pain and inflammation, and mobility issues.It was communicated there is no history of metal, drug, or environmental allergies and that the results for the metal testing were negative; however, as of the date of this medical investigation, the requested clinical documentation has not been provided.Reportedly, the issue is ongoing even though participating in continuous physical therapy.Without the medical documentation, definitive contributing clinical factors cannot be concluded.However, exuberant scar formation is a known potential post-operative occurrence and is not indicative of a component malperformance.The patient impact beyond the reported closed manipulation due to excessive scar tissue, and persistent mobility issues along with pain/inflammation cannot be determined.Correspondence indicated the patient is seeking a second opinion.Should the medical documentation become available in the future, the clinical/medical task would need to be re-evaluated.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.For the legion ps oxinium femoral, genesis ii non-porous tibial baseplate and resurf patellar prosthesis, 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.For the legion ps high flex xlpe, a review of complaint history revealed a similar event 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 in the possible adverse effects that decreased range of motion and 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.Skin sloughs or delayed wound healing has also been identified as a possible adverse effect.Additionally, the warnings and precautions section revealed that postoperative therapy should be structured to prevent excessive loading of the operative knee and to encourage bone healing.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 products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, joint tightness, healing issues, patient condition and/or postoperative care.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: LEGION PS OXIN FEM SZ4 LT
• 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: 17675053
• Report Number: 1020279-2023-01699
• Device Sequence Number: 12390364
• Product Code: JWH
• UDI-Device Identifier: 00885556029121
• UDI-Public: 00885556029121
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2023

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 Catalogue Number: 71421214
• Device Lot Number: 22FM17761H
• 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: 08/08/2023
• Supplement Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 09/03/2023
• Supplement Report FDA Received Date: 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2022
• 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: 71420164/22JM02854/GNS II CMT TIB SIZE 3 LEFT.; 71420574/21GM02353/GNS II RESURF PAT 29MM.; 71453211/22HM10043/LGN PS HIGH FLEX XLPE SZ 3-4 9M.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female