MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN HK FEM ASSEMBLY SZ 5 RT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71421365
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a tka had been performed on 09-apr-2016, the patient underwent a revision surgery on (b)(6)2023 due to an unspecified adverse event, where the lgn hk fem assembly sz 5 rt was exchanged.Patient's current health status is unknown.
Additional Manufacturer Narrative
H3, h6: the associated devices were returned and evaluated.A visual inspection of the returned devices reveal multiple pieces are fractured into pieces.The visual reveal dried cement on the patella.The devices show signs of wear.A lab analysis was performed to examine the devices using visual and macroscopic/microscopic methods.Visual examination showed fracture, delamination, discoloration, and bone fixation of the patella component, fracture of the femoral link component and delamination of several components.No damage was observed on the post sleeve component.Macroscopic/microscopic examination showed burnishing wear, embedment, scratches, and damage.Burnishing wear and embedment of particles on the articular surface of the insert, scratches on the articular surface of the patella component, damage on the screw head of the insert lock screw.No additional features were noted.No evidence of deviation in processing or material was found for the retrieved item.No definitive conclusions as to the cause of these observations can be determined.The clinical/medical evaluation concluded that without the requested supporting clinical documentation, the definitive clinical root cause of the unspecified adverse event could not be determined.Of note, the device was insitu for seven years prior to the revision.Since the health status of the patient is unknown, the impact to the patient beyond that which has already reported cannot be confirmed nor concluded.Should any additional relevant medical information be provided, this cause would be re-assessed.For the patella, the part and batch number for were not provided, thus, an evaluation of the manufacturing records, complaint history, instructions for use, risk management and prior actions review could not be performed.For the insert and the femoral assembly, a review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use document for knee systems provides complete guidelines of indications, contraindications, warnings and precautions and possible adverse effects that may occur preoperative, during surgery or post operative.A review of the risk management and information for use files revealed this failure mode was 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.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.No details about the cause of the revision surgery were provided, therefore no factors that can contribute can be delineated.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.
Event or Problem Description
It was reported that, after a tka was performed on (b)(6) 2016, the patient underwent a revision surgery on (b)(6) 2023 due to an unspecified adverse event, where the lgn hk fem assembly sz 5 rt was exchanged.In addition, one (1) legion hk gd motion isrt 15mm sz 2-3 rt and one (1) unknown legion total knee resurfacing patellar component were explanted.Patient's current health status is unknown.

• Brand Name: LGN HK FEM ASSEMBLY SZ 5 RT
• 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: 17198838
• Report Number: 1020279-2023-01363
• Device Sequence Number: 5440827
• Product Code: KRO
• UDI-Device Identifier: 00885556414934
• UDI-Public: 00885556414934
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K081111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2023

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 Expiration Date: 10/18/2020
• Device Model Number: 71421365
• Device Catalogue Number: 71421365
• Device Lot Number: 13GBP0092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2023
• Supplement Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2013
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LGN HK ISRT 15MM SZ2-3RT(PN:71423346,LN:12MM00618).; UNKNOWN LGN RSRFCNG PAT CMP.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown