MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN OX CONSTRAINED FEM 4 RT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71421174
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).
Event or Problem Description
It was reported that, after tka surgery had been performed approximately 7 years ago, the patient who was highly active experienced pain from the tibia and femur.Surgeon mentioned that radiolescuent lines are visible on the xray which indicated implant loosening.This adverse event was solved by revision surgery on (b)(6) 2023 in which current health status of patient is unknown.
Additional Manufacturer Narrative
H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation stated that as of the date of the medical investigation, the requested clinical documentation had not been provided for evaluation.It was noted on the product complaint form that no other patient information is available.Therefore, there were no clinical factors found which would have contributed to the reported event.The patient impact beyond the revision surgery could not be determined.Specific information about the stems involved in the reported event was not provided.Therefore, an evaluation of the manufacturing records, complaint history review, instructions for use, risk management files and prior actions was not be performed.For the femoral component, insert, tibial baseplate and screws, a review of the production orders 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 devices did not reveal similar events for the listed devices.A review of the instructions for use documents for knee systems revealed that looseness of components can 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.This has been identified in possible adverse events.A review of the risk management 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 these products and events.At this time, we have no reason to suspect that the products 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 devices 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 OX CONSTRAINED FEM 4 RT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: 17113801
• Report Number: 1020279-2023-01283
• Device Sequence Number: 12379218
• Product Code: JWH
• UDI-Device Identifier: 03596010543905
• UDI-Public: 03596010543905
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2023

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 Model Number: 71421174
• Device Catalogue Number: 71421174
• Device Lot Number: 19GM10660
• 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: 05/23/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 07/17/2023
• Date Device Manufactured: 07/16/2019
• 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: GII PS HI FLEX ISRT SZ 1-2 18, LOT:14CT40167; LGN REV TIBIA BASE SZ 2 RT, LOT#:19MM15634
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown