MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION CON ART INS 9MM SZ 5-6; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71420537
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Scar Tissue (2060); Synovitis (2094); Arthralgia (2355); Joint Laxity (4526)
Date of Event	01/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a right tka revision with inlay exchange had been performed on (b)(6) 2022 due to right knee joint stability and subluxation due to multiple falls, the patient sustained a mechanical complication of the right knee prosthesis with inlay loosening, persistent joint pain and synovitis that made necessary a second tka revision surgery to exchange one (1) legion con art ins 9mm sz 5-6 to a 11mm legion constrained inlay.An arthrotomy and partial synovectomy were also performed during this procedure.The patient was discharged without any complications.His current heath status was reported as good.
Additional Manufacturer Narrative
Section d10 and h6 were updated.Section h10: the associated device was returned and evaluated.The visual inspection revealed scratches and deep gouges in the surface of the device.The device shows signs of wear.The clinical/medical investigation concluded that, based on the documentation provided, no definitive clinical factor could be concluded to have been the root cause of the reported ¿very easy to remove the inlay from the tibial platform¿ versus ¿the inlay is reduced, but can be manually dislocated with strong pressure¿; however, it is documented that the 23.06.2022 1st revision/9mm pe ¿insertion is somewhat difficult, but it is safe in the end¿ and along with the history of patient falls could not be ruled out as potential contributing factors.The visual inspection ¿did not reveal the stated failure mode¿.The patient impact includes the reported ¿mechanical complication¿ with inlay loosening, joint pain, synovitis w/scarring and surgical procedures/revision reportedly, the patient status is good.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 system revealed looseness of components as a 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, this has been identified as 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 specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, patient anatomy or abnormal loading of limb.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.Internal complaint reference number: case-(b)(4).
Additional Manufacturer Narrative
Corrected data: h6 (investigation findings).Updated results of investigation: the associated device was returned and evaluated.The visual inspection revealed scratches and deep gouges in the surface of the device.The device shows signs of wear.The clinical/medical investigation concluded that, based on the documentation provided, no definitive clinical factor could be concluded to have been the root cause of the reported ¿very easy to remove the onlay from the tibial platform¿ versus ¿the onlay is reduced, but can be manually dislocated with strong pressure¿; however, it is documented that the 23.06.2022 1st revision/9mm insert ¿insertion is somewhat difficult, but it is safe in the end¿ and along with the history of patient falls could not be ruled out as potential contributing factors.The visual inspection ¿did not reveal the stated failure mode¿.The patient impact includes the reported ¿mechanical complication¿ with inlay loosening, joint pain, synovitis w/scarring and surgical procedures/revision reportedly, the patient status is good.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 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 system revealed looseness of components as a 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, this has been identified as 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 specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, patient anatomy or abnormal loading of limb.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 CON ART INS 9MM SZ 5-6
• 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: 16379159
• Report Number: 1020279-2023-00335
• Device Sequence Number: 17662762
• Product Code: JWH
• UDI-Device Identifier: 03596010555809
• UDI-Public: 03596010555809
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K962137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/19/2023

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 Model Number: 71420537
• Device Catalogue Number: 71420537
• Device Lot Number: B2202110
• 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: 01/23/2023
• Supplement Date Received by Manufacturer: 06/07/2023; 06/07/2023
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 06/08/2023; 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2022
• 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: PN: 71424015/ LN: UNKNOWN; PN: 71424029/ LN: UNKNOWN; PN: 71424031/ LN: UNKNOWN; PN: 71424225/ LN: UNKNOWN; PN: 71426006/ LN: UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male