MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN POR CR HA FEM SZ 5 RT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	71425215
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	04/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a right tka surgery was performed on (b)(6) 2023 with a journey/legion system, the patient presented moderate stiffness on the right knee on (b)(6) 2023.This adverse event was treated with procedure/surgery (knee manipulation) on (b)(6) 2023.This adverse event is ongoing.Patient current health status is recovering.No further complications were reported.
Additional Manufacturer Narrative
Complaint reference number: (b)(4).
Additional Manufacturer Narrative
H3, h6: given the nature of the alleged incident, the devices, could not be returned for evaluation.The clinical/medical investigation concluded that, per complaint details, a manipulation under anesthesia was performed approximately post right total knee arthroplasty due to stiffness.The concomitant procedure log form documented the adverse event start date as 24-april with manipulation under anesthesia procedure performed 3 weeks later.Correspondence indicated the patient is recovering.The post-op instructions and if patient was adherent is unknown.Based on the information provided, definitive contributing clinical factors to the reported postoperative stiffness could not be concluded; however, this is a known potential surgical/procedural complication.The impact to the patient beyond the reported stiffness and subsequent manipulation under anesthesia cannot not be determined based on the information provided.No further medical assessment can be rendered at this time.For the legion porous cr ha fem, device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.For the other devices 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 porous cr ha fem, a review of complaint history for the previous 12 months did not reveal similar events for the listed device.For the other devices 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.A review of the instructions for use documents for knee systems revealed in warnings and precautions, postoperative section that use extreme care in patient handling is needed and postoperative patient care and directions and warnings to patients by physicians are extremely important.Protected weight bearing with external support is recommended for a period of time to allow healing.Normal daily activity may be resumed at the physician¿s direction.Patients should be directed to seek medical opinion before entering potentially adverse environments that could affect the performance of the implant.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, patient condition or postoperative care.Based on this investigation, the need for corrective action is not indicated.Should the devices 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 information: d10 corrected data: d4 (lot number).

• Brand Name: LGN POR CR HA FEM SZ 5 RT
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• 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: 17102355
• Report Number: 1020279-2023-01269
• Device Sequence Number: 13936095
• Product Code: MBH
• UDI-Device Identifier: 00885556108505
• UDI-Public: 00885556108505
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K091543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2023

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: 71425215
• Device Catalogue Number: 71425215
• Device Lot Number: UNKNOWN
• 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: 05/19/2023
• Supplement Date Received by Manufacturer: 11/27/2023
• Initial Report FDA Received Date: 06/11/2023
• Supplement Report FDA Received Date: 11/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 71425303/22EM06121/POROUS TIBIA BSEPLATE W/JRNY LO; 71425371/21JM02054/LGN DD XLPE INS W/ JRNY LOCK SZ; 74025464/21HM08806/POROUS ROUND PATELLA SZ 32MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 81 KG