MAUDE Adverse Event Report: SMITH & NEPHEW, INC. G2 CONST INSRT SZ1-2 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number 71420960

Device Problems Positioning Failure (1158); Unstable (1667)

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

Event Date 04/13/2023

Event Type  malfunction  

Event Description

It was reported that during a tka surgery, when installing the g2 const insrt sz1-2 11mm, it was found that the gap between the insert and the tibial baseplate was large, the insert was unstable and there was a risk of dislocation.The procedure was resumed, after a significant delay, with a s+n back-up device.Patient was not injured as consequence of this problem.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

The associated device was returned and evaluated.The visual inspection does not reveal the stated failure mode.The returned device has damage along the base, more than likely from attempted insertion.A dimensional evaluation performed on the device revealed that the device sent in for evaluation has batch e2126239, however, the batch reported in the complaint is e2126252.The dimensional evaluation was performed on batch e2126239 and it could not confirm or explain the stated failure mode.The device has signs of damage from attempted use.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.However, based on the information provided, the unsatisfactory experience could be confirmed.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the device did not reveal similar events for the listed devices.A review of the risk management files 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 these products and event.According with inspection procedure, the final inspection includes the verification of part configuration per print.Also, per work instructions, the lock detail shall be inspected.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include size selected or insertion technique.Based on this investigation, the need for corrective action is not indicated.Should 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: G2 CONST INSRT SZ1-2 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: 16896985
• MDR Text Key: 314846822
• Report Number: 1020279-2023-01008
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 03596010210104
• UDI-Public: 03596010210104
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K962137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71420960
• Device Catalogue Number: 71420960
• Device Lot Number: E2126239
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Female