MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII MOD BICONVEX PAT REAMR 32M; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71440640

Device Problems Connection Problem (2900); No Fail-Safe Mechanism (2990)

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

Event Date 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that genesis ii mod biconvex pat reamr 32m does not lock on shaft.Tka procedure was performed.No harm or injury reported on patient.Procedure was finished with a smith and nephew back up device.No delay reported.

Manufacturer Narrative

The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirmed the stated failure mode.The device is bent or damaged, rendering the device inoperable.The device was manufactured in 2006 and shows signs of extensive use.A functional evaluation confirmed that this 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.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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.

• Brand Name: GII MOD BICONVEX PAT REAMR 32M
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10889343
• MDR Text Key: 217896448
• Report Number: 1020279-2020-06671
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010464897
• UDI-Public: 03596010464897
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/08/2021

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 Expiration Date: 02/15/2016
• Device Model Number: 71440640
• Device Catalogue Number: 71440640
• Device Lot Number: 06AM01310
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/23/2020
• Supplement Dates Manufacturer Received: 01/07/2021
• Supplement Dates FDA Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1