MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 5-6 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71453222
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/26/2022
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 surgery was performed on 2012, one (1) lgn ps high flex xlpe sz 5-6 11mm broke.This adverse event was treated by a revision surgery on (b)(6) 2022, in which the lgn ps high flex xlpe sz 5-6 11mm was exchanged.No delay reported.Patient's current health status is unknown.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.The visual inspection revealed the post of the device has fractured off.A lab analysis performed on the device revealed that the articulating and non-articulating surfaces of the insert are worn with some discoloration.The post was fractured at the base of the insert and exhibited signs of wear and deformation.There were no observations of material or manufacturing deviations in the course of this investigation.The clinical/medical investigation concluded that, the provided undated x-ray and two photos were reviewed but do not aid in the clinical investigation of the root cause of the reported fracture of post.As of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.The patient's current condition is unknown, and the patient impact beyond the surgery and recovery, could not be determined based on the limited information provided.No further medical assessment could be rendered at this time.Should any additional clinical information be provided, this complaint will be re-evaluated 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 revealed similar a event for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for knee systems revealed that has been identified as a in warnings and precautions that the implant can break or become damaged as a result of strenuous activity or trauma.The patient should be warned that the device does not replace normal healthy bone.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.Verifying the device configuration according to the print is within the steps of the final inspection.Also, the quality and manufacture of 7.5 mrad cross-linked uhmwpe bar should be controlled according to the material specification.A review made by the quality engineering team revealed that the root cause of the fracture of the post could not be determined based on the limited information provided.Also there were no observations of material or manufacturing deviations in the course of this investigation.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.With the results of this investigation the root cause of this event could not be determined.Factors that could contribute to the reported event include traumatic injury or abnormal loading of limb.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 for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 5-6 11MM
• 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: 15626136
• Report Number: 1020279-2022-04444
• Device Sequence Number: 5978746
• Product Code: JWH
• UDI-Device Identifier: 00885556035351
• UDI-Public: 00885556035351
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/23/2022
• Device Model Number: 71453222
• Device Catalogue Number: 71453222
• Device Lot Number: 12KM18860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2022
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown