MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN HK AXLE SZ 7 FEMUR; PRSTHSISKNEEFMROTIBLCNSTRAINDCMENTDMETL/POLYMR

Model Number	71421938
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to hinge knee failure.Surgeon performed a gut exchange, replacing the hinge joint, not taking out cemented implants.
Additional Manufacturer Narrative
The devices, used in treatment, were not returned for evaluation.A visual inspection of the attached picture confirmed the stated failure mode.The insert and sleeve fractured into numerous pieces.The medical investigation concluded that it was reported that a revision surgery was performed due to hinge knee failure.Surgeon performed a ¿gut exchange¿, replacing the hinge joint, not taking out cemented implants.No clinical/medical documents were provided to support this complaint.Only a picture of the removed components was sent with the complaint.Without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.A review of complaint history did not reveal additional complaints for the listed batches.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 potential failure modes were previously identified.Some potential probable causes of the event could include malalignment or traumatic event.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 complaints will be reopened.No further investigation warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: LGN HK AXLE SZ 7 FEMUR
• Common Device Name: PRSTHSISKNEEFMROTIBLCNSTRAINDCMENTDMETL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9398878
• Report Number: 1020279-2019-04250
• Device Sequence Number: 14118286
• Product Code: KRO
• UDI-Device Identifier: 00885556108833
• UDI-Public: 00885556108833
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K081111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2020

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 Expiration Date: 03/15/2026
• Device Model Number: 71421938
• Device Catalogue Number: 71421938
• Device Lot Number: 16BTM0007A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 11/05/2019
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 03/03/2020
• 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