MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIB TR INS SZ3-4/8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71436133

Device Problem Break (1069)

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

Event Date 03/23/2021

Event Type  malfunction  

Event Description

It was reported that during inspection in warehouse the devices were found defectives.The tibial spacer block standar was noticed with an unspecific failure mode ((b)(4)).The journey femoral implant impactor bumper right ((b)(4)) was noticed broken.The journey ii bcs articular insert trial size 1-2 12 mm left ((b)(4)), universal insert spacer size 1-2 18 mm ((b)(4)), journey uni tibia trial insert size 3-4/ 8 mm ((b)(4)), universal insert spacer size 1-2 13 mm ((b)(4)) and journey uni tibia trial insert size 3-4/ 9 mm ((b)(4)) were noticed crack.

Manufacturer Narrative

H3, h6: the device, intended for use in treatment, was not returned for evaluation and the reported event could not be confirmed.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 did not reveal additional complaints for the listed batch.At this time, we have no 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.Without the return of the actual product involved, our investigation could not proceed.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: JOURNEY UNI TIB TR INS SZ3-4/8MM
• 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: 11683500
• MDR Text Key: 252290358
• Report Number: 1020279-2021-03071
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 03596010588104
• UDI-Public: 03596010588104
• Combination Product (y/n): N
• PMA/PMN Number: K113038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71436133
• Device Catalogue Number: 71436133
• Device Lot Number: 20DM13185
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1