MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 7-8 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71453231
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a scientific paper meeting from the australian orthopaedic association held on (b)(6) 2023.From one abstract titled ¿tibial post fracture in legion and genesis ii posterior stabilized total knee replacements¿, 1 patient sustained revision surgery on the left knee on (b)(6) 2023 due to tibial post fracture of a legion posterior stabilized high flex highly cross linked polyethylene size 7-8 9mm.Current patient health status is unknown.No further information is available.
Additional Manufacturer Narrative
This complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from literature sources that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.(b)(4).
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, it was reported that the patient had a revision of the left knee on (b)(6) 2023 due to tibial post fracture of the cross linked polyethylene.The provided abstract was reviewed.The images in the abstract have been interpreted within the text; therefore, no further analysis of the images is required.As of the date of this medical investigation, patient-specific supporting clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the reported events.The patient impact beyond the reported revision cannot be determined with the information provided.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 revealed similar events 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 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, 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 to material specification, the quality and manufacture of polyethylene 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.Factors that could contribute to the reported event include size selected, postoperative care, patient anatomy, abnormal loading of limb, excessive forces and/or traumatic injury.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
H3, h6.The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, it was reported that the patient had a revision of the left knee on (b)(6) 2023 due to tibial post fracture of the cross linked polyethylene.The provided abstract was reviewed.The images in the abstract have been interpreted within the text; therefore, no further analysis of the images is required.As of the date of this medical investigation, patient-specific supporting clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the reported events.The patient impact beyond the reported revision cannot be determined with the information provided.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 revealed similar events 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 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, 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 to material specification, the quality and manufacture of polyethylene 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.Factors that could contribute to the reported event include size selected, postoperative care, patient anatomy, abnormal loading of limb, excessive forces and/or traumatic injury.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 7-8 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: 16644829
• Report Number: 1020279-2023-00711
• Device Sequence Number: 17666619
• Product Code: JWH
• UDI-Device Identifier: 00885556034620
• UDI-Public: 00885556034620
• 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 Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/17/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/07/2024
• Device Model Number: 71453231
• Device Catalogue Number: 71453231
• Device Lot Number: 14GM03220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2023
• Supplement Date Received by Manufacturer: 05/11/2023; 05/11/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 05/16/2023; 05/17/2023
• Date Device Manufactured: 07/07/2014
• 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: Other
• Patient Sex: Unknown