MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN POROUS CR FEM SZ 5R; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	71423255
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka surgery performed on (b)(6) 2022, one (1) lgn porous cr fem sz 5r was loose.This adverse event was solved by a revision surgery on 31-jan-2024, in which the implants were removed and replaced with cemented revision knee implants.It is unknown the current health status of patient.
Additional Manufacturer Narrative
H10: internal complaint reference: case (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 two follow-up x-ray photos, dated 9-12-2023, were provided which demonstrate radiolucency under the medial and anterior tibial baseplate.There may be some radiolucency around the femoral component as well but cannot confirm.A photo of the explanted baseplate was provided which does have some bone still attached but does not confirm a root cause.The instructions for use for knee systems lists possible adverse events: intra-operatively, failure to use the optimum size component may result in loosening, bending, cracking, or fracture of the component and/or bone.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.Without supporting clinical documentation or the pre and post implantation radiographs, we are unable to conclude whether the component loosening was a result from a failure to achieve adequate fixation in the primary surgery or if an external event led to the disassociation of the insert from the baseplate.Consequently, the definitive clinical factors to the insert loosening could not be concluded and none of the events leading up to the loosening were reported that may be related.Since it has been reported, the current health of the patient is unknown, the impact to the patient beyond the reported loosening, the subsequent revision, and the post-operative convalescent period cannot be confirmed nor concluded.Furthermore, it cannot be concluded there was a mal performance of the implant or an implant failure.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the risk management file 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 have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include abnormal motion over time, bone degeneration, inadequate integration between the cement and bone/implant, osteolysis and/or traumatic injury.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.

• Brand Name: LGN POROUS CR FEM SZ 5R
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• 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: 18792034
• Report Number: 1020279-2024-00440
• Device Sequence Number: 18230534
• Product Code: MBH
• UDI-Device Identifier: 00885556031964
• UDI-Public: 00885556031964
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K073325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• 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): 04/01/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71423255
• Device Lot Number: 22BM20470
• 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: 02/05/2024
• Supplement Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2022
• 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: Other; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male