MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN CR HIGH FLEX XLPE SZ 5-6 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71453121
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after tka surgery had been performed on (b)(6) 2023, the patient experienced an infection.This adverse event was solved by a revision surgery on (b)(6) 2024 in which the lgn cr high flex xlpe sz 5-6 9mm was exchanged.Current health status of patient is unknown.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, as of the date of this investigation patient-specific clinical documentation has not been provided; therefore, a clinical root cause for the reported an infection could not be established.The reported adverse event was resolved by performing a revision surgery in which the legion cr high flex xlpe sz 5-6 9mm was exchanged.The impact to the patient beyond the reported infection and the subsequent revision could not be determined since the current health status of the patient is unknown.Should any additional relevant medical information be provided, this case would be re assessed.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for knee systems revealed that acute post-surgical wound infection and late deep wound sepsis have been identified in possible adverse effects section.A review of the risk management file 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 this product and event.A review of the sterilization records revealed the batch was sterilized within normal parameters.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include loss of sterility during procedure, post-operative healing issue, injury, patient condition and/or medical history.Based on this investigation, the need for corrective action is not indicated.Should the device 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.
Additional Manufacturer Narrative
Updated results of investigation: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, as of the date of this investigation patient-specific clinical documentation has not been provided; therefore, a clinical root cause for the reported an infection could not be established.The reported adverse event was resolved by performing a revision surgery in which the legion cr high flex xlpe sz 5-6 9mm was exchanged.The impact to the patient beyond the reported infection and the subsequent revision could not be determined since the current health status of the patient is unknown.Should any additional relevant medical information be provided, this case would be re assessed.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for knee systems revealed that acute post-surgical wound infection and late deep wound sepsis have been identified in possible adverse effects section.A review of the risk management file 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 this product and event.A review of the sterilization records could not be performed given the absence of the lot number.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include loss of sterility during procedure, post-operative healing issue, injury, patient condition and/or medical history.Based on this investigation, the need for corrective action is not indicated.Should the device 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 CR HIGH FLEX XLPE SZ 5-6 9MM
• Common Device Name: 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: 18816452
• Report Number: 1020279-2024-00463
• Device Sequence Number: 12804361
• Product Code: JWH
• UDI-Device Identifier: 00885556033982
• UDI-Public: 00885556033982
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2024

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: 71453121
• Device Lot Number: UNKNOWN
• 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: 02/09/2024
• Supplement Date Received by Manufacturer: 03/26/2024; 10/25/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 03/27/2024; 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown