MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 3-4 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71453211
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Metal Related Pathology (4530); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, a lgn ps high flex xlpe sz 3-4 9mm originally implanted on (b)(6) 2023, had to be revised on (b)(6) 2023, as it had become disengaged from the tibial baseplate.This led to the femoral component wearing on the metal tibial component, leaving metal debris in the joint.The joint was washed out and debrided, and the femoral and tibial components were inspected with some visible damage to the femoral articular surface.The decision was made to leave them insitu, as they were extremely well cemented and the potential damage done removing them outweighed any benefit of replacing them.The patient's bmi made the case extremely difficult, and it is believed, this may have contributed to the poly insert potentially not being locked in properly at time of the primary surgery.The patient was discharged and recovering well, no other complications were reported.
Additional Manufacturer Narrative
Complaint reference number: (b)(4).
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The photographs were reviewed, and revealed that the device shows signs of use.The clinical/medical investigation concluded that, the images provided confirm the disengaged insert.Based on the information provided the patient¿s weight and the report of the poly insert potentially not being locked in properly at time of the primary surgery cannot be ruled out as contributing factors to the reported events.It is presumed that the metal debris originated from the femoral and tibial components articulating while the insert was dislocated.Also noting these components were reportedly left insitu during the revision.As these are damaged components articulating with a revised insert we cannot conclude the success of the revision as could impact the performance of the knee and lifespan of the implanted components.The future impact to the patient beyond the revision cannot be determined.No further clinical assessment is warranted at this time.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 system revealed that looseness of components 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, this has been identified as 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 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 size selected or insertion technique.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 PS HIGH FLEX XLPE SZ 3-4 9MM
• 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: 17113957
• Report Number: 1020279-2023-01286
• Device Sequence Number: 2188323
• Product Code: JWH
• UDI-Device Identifier: 00885556035252
• UDI-Public: 00885556035252
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2023

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: 71453211
• Device Catalogue Number: 71453211
• Device Lot Number: 22GM02968
• 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: 05/17/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 07/07/2023
• Date Device Manufactured: 07/08/2022
• 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: Required Intervention
• Patient Sex: Unknown