MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION PS NP FEM SZ 3 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	71423223
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Inadequate Osseointegration (2646)
Date of Event	06/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Event or Problem Description
It was reported that patient underwent a tka surgery due to due to "rheumatoid arthritis (double knee disease)".It was performed on (b)(6) 2021, eights days after the tka, the patient developed left knee pain and limited activity after rehabilitation exercise at home.Patient continued to carry out functional exercise, and the pain tended to worsen without relief after rest.The film taken in the local hospital showed a fracture around the legion ps np fem sz 3 lt prosthesis that was treated conservatively with plaster.Patient was admitted to the hospital on (b)(6) 2021 for further treatment.Current health status of patient is in good condition and out of the hospital.
Additional Manufacturer Narrative
Section: h3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that based on the documentation provided, the root cause of the reported events was likely multifactorial as the patient comorbidities and intraop findings including the reported periprosthetic femur fracture, loosened femoral prosthesis, and serious osteoporosis could not be ruled out as potential contributing factors to the reported pain, fracture and revision.The patient impact beyond the reported symptoms, intraop findings, treatment and revision could not be determined.No further medical assessment can be rendered at this time.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.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 did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.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 and/or patient condition.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
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The contribution of the device to the reported event could not be corroborated.The clinical/medical investigation concluded that based on the documentation provided, the root cause of the reported events was likely multifactorial as the patient comorbidities and intraop findings including the reported periprosthetic femur fracture, loosened femoral prosthesis, and serious osteoporosis could not be ruled out as potential contributing factors to the reported pain, fracture and revision.The patient impact beyond the reported symptoms, intraop findings, treatment and revision could not be determined.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 did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.The instructions for use documents revealed this failure mode was previously identified.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 or loss of sterility.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: LEGION PS NP FEM SZ 3 LT
• 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; austin, TX 78735 ; 5123913905
• MDR Report Key: 12752003
• Report Number: 1020279-2021-07837
• Device Sequence Number: 20027449
• Product Code: JWH
• UDI-Device Identifier: 03596010611406
• UDI-Public: 03596010611406
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K060742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/07/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71423223
• Device Catalogue Number: 71423223
• Device Lot Number: 20AM25968
• 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: 10/14/2021
• Supplement Date Received by Manufacturer: 11/24/2021; 02/04/2022
• Initial Report FDA Received Date: 11/04/2021
• Supplement Report FDA Received Date: 11/25/2021; 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2020
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female