MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 5-6 12MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71453176
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka surgery, the patient underwent a revision surgery on (b)(6) 2022 to exchange the legion ps high flex xlpe sz 5-6 12mm due to infection.Current health status of the patient is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, an insert revision (¿washout and poly exchange¿) was performed due to infection.It was communicated that the requested clinical documentation is unavailable, and the current health status of the patient is unknown.Without the requested medical documentation, the clinical root cause of the reported infection could not be concluded.Infection is a known possible complication of joint surgery and there is no supporting evidence that the infection was associated with the implant.The patient impact beyond the reported infection with subsequent "washout" and insert revision could not be determined as the current patient status remains unknown.No further medical assessment could be rendered at this time.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, late deep wound sepsis and/or low-grade synovitis has been identified as a possible adverse effect.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but are not limited to contamination, patient reaction, and post-operative healing issue.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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 PS HIGH FLEX XLPE SZ 5-6 12MM
• 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: 15038104
• Report Number: 1020279-2022-03318
• Device Sequence Number: 6943996
• Product Code: JWH
• UDI-Device Identifier: 00885556487099
• UDI-Public: 00885556487099
• 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 Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2022

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 Model Number: 71453176
• Device Catalogue Number: 71453176
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown