MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN POR HA TIB BASE W/O HOLES SZ 5 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71934164
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Osteopenia/ Osteoporosis (2651); Joint Laxity (4526)
Date of Event	04/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, based on the surgeon¿s statement, ¿he may have been pushing in the indication for the porous implant.¿ therefore, a procedural variance cannot be ruled out as the likely cause of the reported adverse event.Although we cannot rule out excessive compressive load prior to full integration of the tibial plateau, implant selection and the patient history of osteopenia as contributory factors.¿it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.¿ the patient's post op plan and health status are not known.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 instructions for use documents for knee systems revealed that improper fixation, and/or migration of the components could cause possible adverse effects.Also, the warnings and precautions section establishes that the implant can become damaged as a result of strenuous activity or trauma.The patient should be warned of surgical risks, and made aware of possible adverse effects.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 surgical technique used or user/procedural variance.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.
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Event or Problem Description
It was reported that after a tka that took place on (b)(6) 2023, the tibial component subsided and tipped into valgus.A revision surgery took place on (b)(6) 2024 to address this event.Patient presented osteopenia.Current patient status is unknown.

• Brand Name: LGN POR HA TIB BASE W/O HOLES SZ 5 LT
• 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: 19316123
• Report Number: 1020279-2024-00933
• Device Sequence Number: 20731025
• Product Code: JWH
• UDI-Device Identifier: 00885556143285
• UDI-Public: 00885556143285
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K933958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2024

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?: No
• Device Catalogue Number: 71934164
• Device Lot Number: 20GM15407
• 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: 04/18/2024
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GNS II POR FEM SIZE 5 LEFT / 71420040; LGN CR HIGH FLEX XLPE SZ 5-6 9MM / 71453121; PRO METAPH TIB STEM 18MM / 71501010
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown