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

Catalog Number	71425206
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	10/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a left tka surgery had been performed on (b)(6) 2023, the patient experienced mild rash in september and mild left knee stiffness on (b)(6) 2023.This adverse event was treated with left knee manipulation under anesthesia on (b)(6) 2023.Patient is recovering.
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 left knee manipulation under anesthesia with cortisone injection was performed approximately 3 months post total knee arthroplasty after the onset of a non-related mild rash in september, followed by the onset of mild left knee stiffness late october.The provided forms indicate the mild adverse device effect was possibly related to the study device and/or the study procedure with an outcome of recovering/resolving post concomitant procedure/ with steroid injection.Based on the information provided within the forms, definitive contributing factors cannot be concluded, although arthrofibrosis/scar tissue is a known common post-surgical occurrence which does not support a component malperformance.Reportedly, the patient is recovering.The patient impact beyond the reported mild left knee stiffness and subsequent manipulation under anesthesia with injection cannot be determined.For the femoral, a review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the tibia baseplate and the insert, devices batch numbers were not provided, thus, an evaluation of the manufacturing records could not be performed.For the femoral, 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.For the tibia baseplate and the insert, a review of complaint history over 12 months revealed a similar event for the listed devices, 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 although rare allergic reactions in patients following joint replacement have been reported.Implantation of foreign material in tissues can result in histological reactions involving macrophages and fibroblasts.Additionally, 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 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, alignment, patient condition and/or postoperative care.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 6 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: 18274933
• Report Number: 1020279-2023-02404
• Device Sequence Number: 6984012
• Product Code: MBH
• UDI-Device Identifier: 00885556108567
• UDI-Public: 00885556108567
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71425206
• Device Lot Number: 19CHA0017A
• 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: 11/16/2023
• Supplement Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 01/11/2024
• Date Device Manufactured: 08/30/2021
• 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: MEDICATION PRESCRIBED FOR DAY OF SURGERY:ACETAMI.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 88 KG