MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 5-6 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71421515
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	12/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during tka, it was found that the outer packaging of one (1) gii ps hi flex isrt sz 5-6 9mm was intact with no signs of tampering, but the inner and outer trays were unsealed and not sterile.With only one prosthesis of each size on hand, the surgeon was forced to use an 11 mm prosthesis instead.The surgeon noted that this switch required additional bone resection, which could potentially harm the patient.The procedure was resumed, after a non-significant delay, with a s+n back-up device.No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
H3, h6: the associated package was returned and evaluated.The visual inspection revealed the device was returned in its original packaging.The first and second part of the inner packaging revealed half of both package seals are open on one side.This inspection was conducted by the naked eye.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review made by the quality engineering team revealed that the vacuum packaging process is the most likely cause of the failure identified.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for knee systems revealed in packaging and labeling that the component should be returned to smith & nephew if the sterile barrier has been broken.Additionally, revealed in sterilization that the implant components are supplied in protective packaging and the packages should be inspected for punctures or other damage prior to surgery.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 the packaging sequence, the component should be placed in a poly bag inside the inner tray.Then the inner tray lid should be securely sealed to the inner tray without any deformations.Then the inner tray should be placed into the outer tray and this should be sealed.At this time, we do have evidence to conclude that the product failed to meet specifications at the time of manufacture.Based on this investigation, the need for corrective action is indicated.Should the package 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 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: 21031321
• Report Number: 1020279-2024-02764
• Device Sequence Number: 4071115
• Product Code: JWH
• UDI-Device Identifier: 03596010492371
• UDI-Public: 3596010492371
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 02/19/2025

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 Catalogue Number: 71421515
• Device Lot Number: 23HM01445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2024
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2023
• 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: Unknown