MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN POR CR HA FEM SZ 4 LT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	71425204
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	07/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference number: (b)(4).H10: smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.
Event or Problem Description
It was reported that after a tka surgery performed on (b)(6) 2023, the patient experienced stiffness on the left knee on (b)(6) 2023.This adverse event was treated with procedure/surgery (knee manipulation).Patient current health status is not recovered.
Additional Manufacturer Narrative
H3, h6: given the nature of the alleged incident, the devices could not be returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that a review of the provided case report forms did not provide any insight into the reported issue of ¿knee stiffness.¿ the patient impact beyond the reported symptoms cannot be determined.Reportedly, the patient symptoms are ongoing, and the patient current health status is ¿not recovered.¿ therefore, no further clinical/medical assessment can be rendered.A review of the devices' production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the femoral component, tibial baseplate and insert, 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 patellar component, the review revealed one 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 and porous knee system revealed in the possible adverse effects and adverse events sections, respectively, 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.A review of the risk management files for all the listed devices 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 alignment or patient condition.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: LGN POR CR HA FEM SZ 4 LT
• 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: 17450635
• Report Number: 1020279-2023-01538
• Device Sequence Number: 20655184
• Product Code: MBH
• UDI-Device Identifier: 00885556108581
• UDI-Public: 00885556108581
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2023

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: 71425204
• Device Lot Number: 21AHA0002A
• 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: 07/11/2023
• Supplement Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 08/24/2023
• Date Device Manufactured: 03/23/2022
• 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: 71425323/POROUS TIBIA BSEPLATE W/JRNY LOCK SZ3 LT.; 71425369/LGN DD XLPE INS W/ JRNY LOCK SZ 3-4 9MM.; 74025464/POROUS ROUND PATELLA SZ 32MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 81 KG