MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION CR NP FEM SZ 6 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 71423206

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Renal Failure (2041); Choking (2464); Renal Impairment (4499)

Event Date 07/18/2023

Event Type  Injury  

Event Description

It was reported that, after a cori assisted tka surgery had been performed on (b)(6) 2023, the patient had one episode of hypotension the day after the operation; the patient also experienced hypokalemia and acute kidney injury; additionally, there was also one episode of choking reported.This resulted in a prolonged hospitalization and was resolved via the use of naloxone, fluids and red blood cells for the hypotension; chlorvescent medication and an idc insertion for the hypokalemia and kidney injury; lastly, the patient was put on thin fluids/soft dysphagia diet due to the choking episode.The patient's status was reported as recovering.

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.

Manufacturer Narrative

Given the nature of the alleged incident, the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, a review of the clinical study documents did not provide any clinical insight into the reported issue of hypotension, hypokalemia, acute kidney injury, and episode of choking.Therefore, there were no clinical factors found which would have contributed to the reported events and a causal relationship cannot be confirmed.The patient impact beyond the reported treatment received during the prolonged hospitalization could not be determined.No further clinical assessment can be rendered at this time.No further clinical assessment is warranted at this time.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 provides complete guidelines of indications, contraindications, warnings and precautions and possible adverse effects that may occur preoperative, during surgery or post operative.A review of the risk management files is not applicable because no information was provided that relates the failure mode to the devices.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 patient medical history and/or post-operative 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.Corrected data: e1 (initial reporter name, us city or (foreign state/province/territory)), g2, h6 (health effect - clinical code, health effect - impact code).

• Brand Name: LEGION CR NP FEM SZ 6 LT
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: 17557650
• MDR Text Key: 321259549
• Report Number: 1020279-2023-01622
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556030035
• UDI-Public: 00885556030035
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K060742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/14/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 71423206
• Device Lot Number: 22BM17472
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2023
• Initial Date FDA Received: 08/16/2023
• Supplement Dates Manufacturer Received: 09/13/2023
• Supplement Dates FDA Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 71420168/GNS II CMT TIB SIZE 5 {} LEFT.; 71421032/GII OVAL RESURFACING PAT 32MM.; 71453121/LGN CR HIGH FLEX XLPE SZ 5-6 9MM.
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 112 KG