MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HK GUIDED MOTION TIB ISRT 13MM SZ 4-5 RT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71423355
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	03/11/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, three months after primary procedure, the patient experienced an acute infection.The patient was admitted to the hospital for irrigation, debridement and insert exchange.Antibiotics were prescribed.The patient was discharged from hospital after about 10 days.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that based on this unfortunate patients history, the root cause of her infections are likely hematogenous and not a s+n device failure.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.A review of sterilization documents indicated that the product was sterilized according to sterilization release documentation.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.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, 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: LEGION HK GUIDED MOTION TIB ISRT 13MM SZ 4-5 RT
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10681285
• Report Number: 1020279-2020-05380
• Device Sequence Number: 2991481
• Product Code: KRO
• UDI-Device Identifier: 00885556108697
• UDI-Public: 00885556108697
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K081111
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2021

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 Model Number: 71423355
• Device Catalogue Number: 71423355
• Device Lot Number: 17BTX0068A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/18/2020
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 07/01/2021
• 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; Life Threatening; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 102