MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN GENESIS II TOTAL KNEE TIB INSERT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Damage to Ligament(s) (1952); Joint Laxity (4526)

Event Date 11/26/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a revision surgery was performed and the patient received a ps poly exchanged and lateral ligament reconstruction using lars.

Manufacturer Narrative

Results of investigation: it was reported that a revision surgery was performed and the patient received a ps poly exchange and lateral ligament reconstruction using lars.The reason for the revision was due to an unstable knee.No additional was provided at this time.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record and complaint history review cannot be completed.There is no information that would suggest the device failed to meet specifications.A medical analysis noted that approximately 6 years post implantation, patient underwent revision surgery per the reported failure.The provided ap x-ray image (likely under stress) shows significantly decreased medial spacing and supports the complaint as well there is a space from the laxity on the lateral side of the knee consistent with lateral ligament insufficiency.The femoral component appears to place the knee in a valgus position but the image does not show enough of the leg to confirm that the mechanical axis was appropriate.Based on the information provided, the reported instability was the root cause of the revision.The patient impact beyond the reported instability, ligament recon and poly revision could not be determined.No further medical assessment could be rendered at this time.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: UNKN GENESIS II TOTAL KNEE TIB INSERT
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11056174
• MDR Text Key: 241252062
• Report Number: 1020279-2020-07692
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1