MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 7-8 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71453232
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Arthralgia (2355)
Date of Event	10/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case- (b)(4).
Event or Problem Description
It was reported that, after tka surgery had been performed on (b)(6) 2011, the patient experienced pain.As a result of this adverse event, a revision surgery was performed on (b)(6) 2023, in which a broken lgn ps high flex xlpe sz 7-8 11mm was exchanged.Current health status of patient remains unknown.
Additional Manufacturer Narrative
Section h3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, based on the information provided, the definitive clinical root cause of the reported pain and post breakage cannot be determined.Of note, the implant remained insitu for approximately 12 years prior to the revision.The patient impact was the reported pain, post breakage and the subsequent revision.Further impact would include the additional recovery time, pain management, and return office visits as a result of the revision.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 in warnings and precautions that the implant can break or become damaged as a result of strenuous activity or trauma.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 inspection drawing, the visual inspection includes the verification of part configuration per print.Also, 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 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 associated device was returned and evaluated.The visual inspection revealed the post fractured off the implant.The implant shows signs of wear.The knee insert post deformation and/or fracture may have been due to repeated posterior contact of the femoral cam on the post combined with excessive posterior to anterior shear force during activity.However, this could not be isolated as the root cause for this particular failure mode.Based on the conclusions of the product history review and the device evaluation, further product evaluation is not required because there is no evidence that a manufacturing deficiency occurred.The clinical/medical investigation concluded that, based on the information provided, the definitive clinical root cause of the reported pain and post breakage cannot be determined.Per the instruction for use for the knee systems; ¿the implant can break or become damaged because of strenuous activity or trauma and has a finite expected service life and may need to be replaced in the future.¿ of note, the implant remained insitu for approximately 12 years prior to the revision.The patient impact was the reported pain, post breakage and the subsequent revision.Further impact would include the additional recovery time, pain management, and return office visits as a result of the revision.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, however, no commonalities that would suggest a device deficiency was found nor an adverse trend.No similar events for the batch based on the historical data were found, this failure mode will be monitored for future complaints for any necessary corrective actions.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 inspection drawing, the visual inspection includes the verification of part configuration per print.Also, per the material specification, the quality and manufacture of polyethylene shall be controlled.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.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 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: 18141479
• Report Number: 1020279-2023-02245
• Device Sequence Number: 6467743
• Product Code: JWH
• UDI-Device Identifier: 00885556035153
• UDI-Public: 00885556035153
• 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: 2011
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/12/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/17/2021
• Device Catalogue Number: 71453232
• Device Lot Number: 11AM10569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2023
• Supplement Date Received by Manufacturer: 12/07/2023; 02/07/2024
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 12/08/2023; 02/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2011
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown