MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII C/R ART INS SZ 3-4 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number 71420492

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/05/2021

Event Type  malfunction  

Event Description

It was reported that, during a tka surgery setup, a genesis ii cruciate/retaining articular insert size 3-4 11m sterile packaging was noticed to be compromised.The inner bag was not sealed and the insert was outside of the bag, though in the box.Surgery was completed with a backup device instead, without any delay.Patient was not involved.

Manufacturer Narrative

Section h10: the device was not returned for evaluation but the pictures were reviewed, and confirmed the inner bag was not sealed.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 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 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 prior actions related to this device and failure mode, however this batch was not part of the impacted product.The contribution of the device to the reported event could be corroborated since it wasn't used in the procedure because the inner package was already opened.At this time, we do have reason to suspect that the product failed to meet product specifications at the time of manufacture.This issue was evaluated through our internal quality process and a quality hold was initiated as a containment action.An isolated manufacturing process error was identified as the probable root cause.Manufacturing personnel were provided an awareness training to prevent future recurrence of the issue.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Internal complaint reference number: (b)(4).

• Brand Name: GII C/R ART INS SZ 3-4 11MM
• Type of Device: 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: 12201272
• MDR Text Key: 262610655
• Report Number: 1020279-2021-06014
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 03596010207906
• UDI-Public: 03596010207906
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/11/2022

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
• Device Operator: Health Professional
• Device Model Number: 71420492
• Device Catalogue Number: 71420492
• Device Lot Number: 19HT26422
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/09/2021
• Initial Date FDA Received: 07/21/2021
• Supplement Dates Manufacturer Received: 07/22/2022
• Supplement Dates FDA Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/19/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1