MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CMT TIB SIZE 5 RIGHT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number 71420186

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 03/31/2022

Event Type  Injury  

Event Description

It was reported that, during total knee arthroplasty, a box of genesis ii non-porous tibial baseplate size 5 right contained a size 4 left device instead.The outside of the box displayed part no.71420186 and lot no.20cm03707, but the product inside was a 71420166 from lot no.21fm13870.The incorrect device could be removed before cementing hardened or damage occurred.Surgery was resumed, after a non-significant delay, with the same device.Patient was not harmed as consequence of this problem.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, based on the information provided, the root cause of the reported event was human error; however, the exact point of divergence could not be concluded.The patient impact beyond the reported 0-30 minute surgical extension and modified surgical procedure could not be determined, as it was reported that the procedure resumed using the same device without patient harm.No further medical assessment can be rendered at this time.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 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 the label specification and manufacturing records revealed that the tibial baseplate size 5 right should be inside the package, matching label and product with part no.71420186 and lot no.20cm03707.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Manufacturing process errors are likely probable causes of the reported event.The contribution of the device to the reported event could not be corroborated.This event was previously identified, a quality hold has been issued as a containment action and a review of the rebox process is being performed to mitigate its reoccurrence.Based on this investigation, the need for corrective action is 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: GNS II CMT TIB SIZE 5 RIGHT
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
• 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: 14192046
• MDR Text Key: 289952893
• Report Number: 1020279-2022-01941
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 03596010206350
• UDI-Public: 03596010206350
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2022

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
• Device Operator: Health Professional
• Device Model Number: 71420186
• Device Catalogue Number: 71420186
• Device Lot Number: 20CM03707
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/31/2022
• Initial Date FDA Received: 04/25/2022
• Supplement Dates Manufacturer Received: 07/22/2022
• Supplement Dates FDA Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2020
• 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
• Patient Outcome(s): Hospitalization; Other