MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN CR HIGH FLEX XLPE SZ 5-6 9MM; UNCOATED KNEE TIBIA PROSTHESIS, POLYETHYLENE

Model Number	L
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	05/09/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to infection.The poly was explanted.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, responses to the clinical requests were not provided.Per complaint details, the revision was performed due to infection; however, the source of the infection remains unknown.The patient impact beyond the reported infection and subsequent poly revision could not be determined.In the event additional medical/clinical records are received, the clinical task may be re-opened for re-assessment.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.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 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, 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.G1, h6.

• Brand Name: LGN CR HIGH FLEX XLPE SZ 5-6 9MM
• Common Device Name: UNCOATED KNEE TIBIA PROSTHESIS, POLYETHYLENE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10123217
• Report Number: 1020279-2020-02008
• Device Sequence Number: 19545812
• Product Code: JWH
• UDI-Device Identifier: 00885556033982
• UDI-Public: 885556033982
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2021

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: No Information
• Device Model Number: L
• Device Catalogue Number: 71453121
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 05/09/2020
• Supplement Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 06/05/2020
• Supplement Report FDA Received Date: 07/14/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention