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

Model Number L

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 05/09/2020

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to infection.The poly was explanted.

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
• Type of Device: UNCOATED KNEE TIBIA PROSTHESIS, POLYETHYLENE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10123217
• MDR Text Key: 194134647
• Report Number: 1020279-2020-02008
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556033982
• UDI-Public: 885556033982
• Combination Product (y/n): N
• PMA/PMN Number: K071071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: No Information
• Device Model Number: L
• Device Catalogue Number: 71453121
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 05/09/2020
• Initial Date FDA Received: 06/05/2020
• Supplement Dates Manufacturer Received: 07/14/2021
• Supplement Dates FDA Received: 07/14/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention