MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 1-2 12MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71453172
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/19/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was conducted because the patient presented an infection and fever.The surgeon says the devices were not defective.Patient outcome is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms this case reports a revision was performed was performed due to infection and fever, and the surgeon says the devices were not defective.To date, the requested surgical records and x-rays have not been provided to fully evaluate the root cause of the reported event.Therefore, patient impact beyond the revision cannot be determined.No further medical assessment is warranted at this time.Should clinically relevant documentation or information become available, the clinical/ medical task may be re-evaluated.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This included a review of sterilization documents which indicated that the product was sterilized according to sterilization release documentation.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Infection, a potential complication associated with any surgery, can occur and possible causes could include but not limited to contamination, patient reaction, and post-operative healing issue.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 1-2 12MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10681881
• Report Number: 1020279-2020-05410
• Device Sequence Number: 19573776
• Product Code: JWH
• UDI-Device Identifier: 00885556486894
• UDI-Public: 00885556486894
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2021

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 Expiration Date: 11/07/2025
• Device Model Number: 71453172
• Device Catalogue Number: 71453172
• Device Lot Number: 15LM07074
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 06/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention