MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS UNI LM/RL MD TIB BASE; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 726202

Device Problem Positioning Problem (3009)

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

Event Date 11/25/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during surgery, while getting the implants ready for implantation (outside the patient), the surgeon was unable to engage the polyethylene insert into the tibial baseplate.It was decided to open a separate polyethylene insert and that failed to engage either.A second tibial baseplate was opened and the insert engaged as expected.It was deduced that there was an issue with the tibial baseplate that did not allow the insert to engage, there was not a problem with the inserts.There was no delay.No other complications were reported at this time.

Manufacturer Narrative

The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device has minor scratches on the device.The device was manufactured in 2014 and shows signs of moderate use.A functional evaluation confirmed that the device was paired with mating part mechanism and does not function as intended.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.The potential probable causes for this event could include but not limited to a user or procedural error.Based on this investigation, the need for corrective action is not indicated.Without the actual products involved and/or device information, our investigation cannot proceed.If these devices or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: GNS UNI LM/RL MD TIB BASE
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11055733
• MDR Text Key: 241252534
• Report Number: 1020279-2020-07684
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: K912735
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2024
• Device Catalogue Number: 726202
• Device Lot Number: 14DM05509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2021
• Date Manufacturer Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1