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

Model Number	71421516
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint reference number: case (b)(4).
Event or Problem Description
It was reported that, after tka surgery had been performed on (b)(6) 2009, the patient experienced a fracture of a gii ps hi flex isrt sz 5-6 11 post.This adverse event was solved by a revision surgery performed on (b)(6) 2023, where an insert was removed, and a new one was implanted.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation.However, the photographs were reviewed, and revealed that the post of the insert broke off.The clinical/medical investigation concluded that, per complaint details, a revision was performed approximately 14 years post implantation due to the patient experienced a fractured insert post.It was communicated that ¿the surgeon said the patient did have a fall on the knee¿.Based on correspondence, the current patient status is unknown, and the requested clinical documentation is not available.Based on the information provided, the reported patient fall could not be ruled out as a contributing factor to the reported event.Further patient impact cannot be determined.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.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.According with the process procedure, the inspection includes the verification of part configuration per print.Also, per material specification, the quality and manufacture of ultra-high-molecular-weight polyethylene 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.

• Brand Name: GII PS HI FLEX ISRT SZ 5-6 11
• 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: 17084157
• Report Number: 1020279-2023-01245
• Device Sequence Number: 11456530
• Product Code: JWH
• UDI-Device Identifier: 03596010492333
• UDI-Public: 03596010492333
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• 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): 07/06/2023

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: 03/29/2019
• Device Model Number: 71421516
• Device Catalogue Number: 71421516
• Device Lot Number: 09CT29536
• 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: 05/16/2023
• Supplement Date Received by Manufacturer: 07/03/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 07/06/2023
• Date Device Manufactured: 03/31/2009
• 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