MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN POROUS CR FEM SZ 6L; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	71423246
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Scar Tissue (2060); Arthrofibrosis (4885)
Date of Event	05/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint reference number: (b)(4).
Event or Problem Description
It was reported that, a tka was performed on (b)(6) 2023, because the patient had arthrofibrosis and experienced stiffness.A lgn porous cr fem sz 6l was implanted, and on week six postoperatively, it was noticed the patient could not flex the knee beyond 90 degrees, therefore the procedure did not solve the patient's condition.The patient was treated with physical therapy and was scheduled for a mua procedure, on (b)(6) 2023.
Additional Manufacturer Narrative
H3, h6: given the nature of the alleged incident, the devices were not returned for evaluation; therefore, a devices analysis could not be performed.The clinical/medical investigation concluded that, based on the information provided, the reported arthrofibrosis which is noted as present prior to the total knee arthroplasty with the total knee arthroplasty to treat it as later noted with difficulty flexing beyond 90 degrees.It cannot be concluded if this was related to the preoperative arthrofibrosis that was complicated with the total knee arthroplasty or if this is further or new arthrofibrosis as a result of the procedure.It¿s not likely related to the smith and nephew device.Arthrofibrosis is a known complication of major knee surgeries due to excessive scar tissue formation.It has been reported an manipulation under anesthesia procedure was planned for this patient on (b)(6) 2023.However, as of the date of this medical investigation, the procedure report nor the patient¿s outcome has not been provided therefore, the patient¿s impact beyond the reported arthrofibrosis, limited range of motion could not be confirmed nor concluded.Should any additional relevant clinical information be provided, this case would be re-assessed.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 possible adverse effects that decreased range of motion, flexion contracture 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.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 events.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.
Event or Problem Description
It was reported that, a tka was performed on (b)(6) 2023, because the patient had arthrofibrosis and experienced stiffness.A lgn porous cr fem sz 6l was implanted, and on week six postoperatively, it was noticed the patient could not flex the knee beyond 90 degrees, therefore the procedure did not solve the patient's condition.The patient was treated with physical therapy and was scheduled for a mua procedure, on (b)(6) 2023.Patient not yet recovered.
Additional Manufacturer Narrative
B5: updated.
Additional Manufacturer Narrative
H6: given the nature of the alleged incident, the device, could not be returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, based on the information provided in 2023, the reported arthrofibrosis which is noted as present prior to the total knee arthroplasty with the total knee arthroplasty to treat it as later noted with difficulty flexing beyond 90 degrees.It cannot be concluded if this was related to the preoperative arthrofibrosis that was complicated with the total knee arthroplasty or if this is further or new arthrofibrosis as a result of the procedure.It¿s not likely related to the smith and nephew device.Arthrofibrosis is a known complication of major knee surgeries due to excessive scar tissue formation.It has been reported an manipulation under anesthesia procedure was planned for this patient on (b)(6) 2023.However, as of the date of this medical investigation, the procedure report nor the patient¿s outcome has not been provided therefore, the patient¿s impact beyond the reported arthrofibrosis, limited range of motion could not be confirmed nor concluded.Based on the new information provided in 2025, the reported arthrofibrosis cannot be linked to a mal-performance of the s&n products.Arthrofibrosis is a known complication of major knee surgeries due to excessive scar tissue formation.Therefore, arthrofibrosis is related to the procedure and it is not considered a foreseeable harm associated with the s&n products.It was reported no further information will be provided and the patient¿s outcome was reported as not resolved.Should any additional relevant clinical information be provided, this case would be re-assessed.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 numbers of the femoral component, tibial baseplate and insert 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 complaint history revealed a similar event for the listed part number of the patellar component 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 possible adverse effects that decreased range of motion, flexion contracture 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.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 evidence to conclude that the products failed to meet any specifications at the time of manufacture.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.

• Brand Name: LGN POROUS CR FEM SZ 6L
• 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: 17102157
• Report Number: 1020279-2023-01265
• Device Sequence Number: 1988973
• Product Code: MBH
• UDI-Device Identifier: 00885556032343
• UDI-Public: 00885556032343
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K073325
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/17/2025

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: 71423246
• Device Catalogue Number: 71423246
• Device Lot Number: 20HHA0026
• 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: 05/18/2023
• Supplement Date Received by Manufacturer: 06/19/2023; 07/06/2023; 10/14/2025
• Initial Report FDA Received Date: 06/10/2023
• Supplement Report FDA Received Date: 06/21/2023; 07/11/2023; 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 88 KG