MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 7-8 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71453233
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/03/2023
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 had been performed in 2013, the patient experienced pain.This adverse event was solved by a revision surgery on (b)(6) 2023, in which it was found that the post of a lgn ps high flex xlpe sz 7-8 13mm had broken off.The insert was replaced with another one with the same exact characteristics.Patient current health status is unknown.
Additional Manufacturer Narrative
The associated device was returned and evaluated.The visual inspection revealed the device was found to be fractured along the post.The fractured post was returned with the rest of the device.The laboratory analysis revealed yellowish discoloration of the insert.Yellowish discoloration of the polyethylene of implants can occur when exposed to fluids in or around a joint, burnishing wear on the articular surface of the insert, damage to the post region surface of the insert, and fracture of the post, the post was fractured approximately at the inferior-superior base, little to no damage was observed on the anterior side of the fractured post, no additional unexpected visual features noted.No evidence of deviation in processing or material was found for the retrieved item.No definitive conclusions as to the cause of these issues can be determined.The clinical/medical investigation concluded that, per complaint details, a revision was performed approximately 9 to 10 years post implantation due to pain and an intraop finding of a fractured insert post.Per correspondence, the requested clinical information is not available.Without the requested medical documentation, definitive clinical factors which could have contributed to the reported event could not be concluded.The patient impact beyond the reported pain and subsequent revision with a finding of a broken post could not be determined.The current health status is unknown.No further medical assessment can be rendered 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 revealed a similar 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 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, this has been identified as warnings and precautions.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.According with the material specification, the quality and manufacture of the polyethylene (uhmwpe) bar stock shall be controlled.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, joint tightness, abnormal loading of the limb and/or patient condition.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 7-8 13MM
• 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: 16265312
• Report Number: 1020279-2023-00194
• Device Sequence Number: 6007001
• Product Code: JWH
• UDI-Device Identifier: 00885556033524
• UDI-Public: 00885556033524
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2023

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: 08/10/2018
• Device Model Number: 71453233
• Device Catalogue Number: 71453233
• Device Lot Number: 08HM07928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2023
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2008
• 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: Male
• Patient Weight: 99 KG