MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 3-4 9; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71421508
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Discomfort (2330)
Date of Event	02/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, a revision surgery had to be done on (b)(6) 2023, after a gii ps hi flex isrt sz 3-4 9 was originally implanted on (b)(6) 2009, because the post of the implant snapped off, and the patient felt instability and clunking in the knee.During the revision surgery only the insert was exchanged, since all the other implants were still solidly fixed.The revision surgery was completed successfully.Patient's current health status is unknown.
Additional Manufacturer Narrative
The device was not returned for evaluation.However, the photograph was reviewed, and revealed that the post of the insert is fractured.The clinical/medical investigation concluded that, the reported instability and clunking feeling in the knee is consistent with symptoms associated with a broken insert post.The photo confirms the breakage but does not indicate a clinical root cause.Based on the limited information provided, we cannot conclude if there were clinical factors that contributed to the breakage of the post versus the time implanted.The patient impact beyond the revision surgery cannot be determined.No further clinical/medical 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.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 procedure, the receiving inspection verifies that parts are free of burrs, pits, sharp edges, nicks or damaged areas.Also, per material specification, the quality and manufacture of polyethylene as ram-extruded rod and compression-molded rod and plate 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 3-4 9
• 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: 16547095
• Report Number: 1020279-2023-00539
• Device Sequence Number: 6042557
• Product Code: JWH
• UDI-Device Identifier: 03596010492357
• UDI-Public: 03596010492357
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 09/14/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/26/2019
• Device Model Number: 71421508
• Device Catalogue Number: 71421508
• Device Lot Number: 09BT28824
• 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: 02/16/2023
• Supplement Date Received by Manufacturer: 09/13/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 09/14/2023
• Date Device Manufactured: 02/28/2009
• 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