MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 3-4 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, ETAL/POLYMER

Model Number	71453211
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that a patient received a poly exchange due to infection.There is no information about the original implants or surgery date.A 3-4 9mm poly was used.
Additional Manufacturer Narrative
Results of investigation: it was reported that a patient received a poly exchange due to infection.There is no information about the original implants or surgery date.A 3-4 9mm poly was used.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As batch information was not made available, device history record and sterilization documentation review cannot be completed.There is no information that would suggest the device failed to meet specifications.A review of risk management files found that the reported failure was documented appropriately.A medical analysis noted that there was good rom & stability and the surgeon does not fault the implant.No medical documents were received for investigation.Based on the limited information provided, the impact to the patient beyond the revision cannot be determined.The source/type of the infection is unknown.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.We will continue to trend through our post market surveillance process.With no medical records or patient medical history provided, our investigation of this report is inconclusive and no root cause can be determined at this time.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 3-4 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, ETAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10957036
• Report Number: 1020279-2020-07054
• Device Sequence Number: 3189561
• Product Code: JWH
• UDI-Device Identifier: 00885556035252
• UDI-Public: 00885556035252
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2021

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: Lay User/Patient
• Device Model Number: 71453211
• Device Catalogue Number: 71453211
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 11/11/2020
• Supplement Date Received by Manufacturer: 03/06/2021
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 03/19/2021
• 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