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

Catalog Number	71423244
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	10/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Event or Problem Description
It was reported that, after a tka surgery performed (b)(6) 2023, the patient experienced an unknown adverse event.The issue was solved with manipulation under anesthesia with intraarticular steroid and local anesthetic injection.The patient current health status is unknown.Further information is not available.
Additional Manufacturer Narrative
Section h3, h6: given the nature of the alleged incident, the devices could not be returned for evaluation.The clinical/medical investigation concluded that, the electronic clinical report form was provided and confirms the compliant however, the do not aid in determining the root cause.As of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.The instructions for use for the knee system does warn, ¿post-operative therapy should be structed to prevent excessive loading of the operative knee and to encourage bone healing.¿ according to the report, the issue was solved with manipulation under anesthesia with intraarticular steroid and local anesthetic injection.The impact to the patient beyond the unknown adverse event, the manipulation under anesthesia and the medications cannot be determined since the current health status of the patient is unknown.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 revealed a similar event for the part numbers for baseplate and the insert 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.This similar event reported an adverse event but no sufficient information about the failure mode was provided, so these events could not be associated with the reported event.For the femoral component 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.A review of the instructions for use documents for knee systems revealed that it a provides complete guidelines of indications, contraindications, warnings and precautions and possible adverse effects that may occur preoperative, during surgery or post operative.As no details of the alleged fault, malfunction or injury were provided a risk management files and prior actions review could not be performed.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.No details of the alleged fault, malfunction or injury were provided, therefore no factors that can contribute can be delineated.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 POROUS CR FEM SZ 4L
• 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: 18209916
• Report Number: 1020279-2023-02325
• Device Sequence Number: 15014556
• Product Code: MBH
• UDI-Device Identifier: 00885556030936
• UDI-Public: 00885556030936
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K073325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 71423244
• Device Lot Number: 20MHA0035
• 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: 10/31/2023
• Supplement Date Received by Manufacturer: 01/05/2024
• Initial Report FDA Received Date: 11/27/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2022
• 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; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 89 KG