MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HK GD MOTION ISRT 18MM SZ 4-5 LT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71423358
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Pain (1994)
Date of Event	08/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after tka surgery, a legion hk gd motion isrt 18mm sz 4-5 lt swap of a hinge knee in which was some pain and infection present.Upon visual of x-ray, it was noticed that the legion patella had sheared off at the pegs, and the set screw was not in the tibial baseplate.This adverse event was solved by revision surgery on (b)(6) 2023, in which femur was opened up, poly replaced with a 13mm, and the patella tracked well and as such was not replaced.Current health status of patient is unknown.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, per complaint details, an insert-swap/revision was performed after an unknown length of time in-vivo due to some pain and infection.It was communicated that the ¿set screw in the insert was not threaded into the baseplate.It was ¿floating¿ in the poly as though it had not been screwed into the baseplate¿.Reportedly, although it was noticed on x-ray that the ¿patella had sheared off at the pegs¿ the ¿patella tracked well and as such was not replaced¿.The patient¿s current health status is reportedly ¿doing well¿ post-revision of 18mm insert/¿replaced with a 13mm¿ insert.It was communicated that the requested clinical information is not available.Without the implantation details/medical documentation, it is unknown if the insert was initially intact therefore, definitive clinical factors cannot be concluded to have contributed to this event.The pain and infection however, were reportedly present along with the findings of a disassociated patella (x-ray) and ¿floating¿ set screw (intraoperatively).Patient impact beyond that which was reported cannot be determined.No further medical assessment can be rendered at this time.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for knee systems revealed that acute post-surgical wound infection and late wound sepsis have been identified in possible adverse effects section.Also the looseness of components has been identified in possible adverse effects section as a result from trauma, improper implant selection, improper implant positioning, improper fixation, and/or migration of the components.Muscle and fibrous tissue laxity can also contribute to these conditions.A review of the risk management file revealed this failure modes were previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.Additionally, since the device batch number was not provided, a review of the sterilization records could not be performed.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include loss of sterility during procedure, post-operative healing issue, traumatic injury, patient condition, patient anatomy, medical history, postoperative care and/or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.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.
Event or Problem Description
It was reported that, after tka surgery, a legion hk gd motion isrt 18mm sz 4-5 lt swap of a hinge knee in which was some pain and infection present.Upon visual of x-ray, it was noticed that the legion patella had sheared off at the pegs, and the set screw was not threaded into the baseplate, it was ¿floating¿ in the poly as though it had not been screwed into the baseplate.This adverse event was solved by revision surgery on (b)(6) 2023, in which femur was opened up, poly replaced with a 13mm, and the patella tracked well and as such was not replaced.Current health status of patient is doing well post-operative.

• Brand Name: LEGION HK GD MOTION ISRT 18MM SZ 4-5 LT
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 17730537
• Report Number: 1020279-2023-01753
• Device Sequence Number: 20356732
• Product Code: KRO
• UDI-Device Identifier: 00885556030813
• UDI-Public: 00885556030813
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K081111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2023

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 Catalogue Number: 71423358
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown