MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 3-4 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71453212
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	11/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint number: case- (b)(4).
Event or Problem Description
It was reported that, after tka surgery had been performed on (b)(6) 2023, the patient experienced infection.This adverse event was treated with a synovectomy, washing of the joint, and revision surgery that were performed on (b)(6) 2023, in which a lgn ps high flex xlpe sz 3-4 11mm was exchanged.Current health status of patient remains unknown.
Additional Manufacturer Narrative
B7: other relevant history, including preexisting medical conditions.Section 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 medical investigation, the requested clinical documentation has not been provided for evaluation.It was noted within the attachments that further information is not available.Therefore, there were no clinical factors identified which would have contributed to the reported infection and a causal relationship between the device and infection cannot be confirmed.Per case details, the surgeon believes the patient¿s comorbidities of smoking and obesity were likely cause of the reported infection.The patient impact is limited to the revision surgery and associated recovery period.No further clinical assessment can be rendered at this time.A review of the production order 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 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 revealed that acute post-surgical wound infection has been identified in possible adverse effects.Active, local infection or previous intra-articular infections are identified in contraindications for total knee replacement.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 reason to suspect 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.E1:initial reporter name and address.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 3-4 11MM
• 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: 18166935
• Report Number: 1020279-2023-02268
• Device Sequence Number: 6541957
• Product Code: JWH
• UDI-Device Identifier: 00885556034170
• UDI-Public: 00885556034170
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2023

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 Catalogue Number: 71453212
• Device Lot Number: 22GM08497
• 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: 11/06/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 11/18/2023
• Supplement Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown