MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 1-2 9; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71421501
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a tka, one (1) gii ps hi flex isrt sz 1-2 9 would not lock with the tibial baseplate.The procedure was resumed, after a significant delay, with a s+n back-up device.Patient was not harmed as a consequence of this problem.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device does not reveal the stated failure mode.The returned device has damage along the base, more than likely from attempted insertion.A dimensional inspection of the returned device could not confirm or explain the stated failure mode.The device has signs of damage from attempted use.A dimensional inspection was attempted; the damage/deformation at several features of the device would not allow for accurate measurement.All applicable, critical features that could be measured were within specification.Based on the evidence provided, the unsatisfactory experience could be confirmed.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 manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A review of instructions for use for knee systems revealed in indications, contraindications, and adverse effects that preoperative planning and meticulous surgical technique are essential to achieve optimum results.Considerations of anatomic loading, soft-tissue condition, and component placement are critical to minimize a variety of complications.Also, revealed in warnings and precautions that surgical information is available upon request and the surgeon should be familiar with the technique.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; 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 1-2 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: 16825641
• Report Number: 1020279-2023-00932
• Device Sequence Number: 17854859
• Product Code: JWH
• UDI-Device Identifier: 03596010492388
• UDI-Public: 03596010492388
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71421501
• Device Catalogue Number: 71421501
• Device Lot Number: 22BT59666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2022
• 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
• Patient Sex: Female