MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. JOURNEY TIBIAL IMPL IMPACTOR; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 74018901

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Information (3190)

Event Date 09/18/2010

Event Type  malfunction  

Event Description

It was reported that a malfunction occurred.The tibia impactor used in the loaner case here at silverdale has flaked off some plastic during surgery.

Manufacturer Narrative

The associated journey tibial implant impactor was not returned for evaluation.The device was manufactured in 2013.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.Without the return of the actual product involved, our investigation of this report is inconclusive.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Should additional information be received, the complaint will be reopened.

• Brand Name: JOURNEY TIBIAL IMPL IMPACTOR
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): SMITH AND NEPHEW, INC.; 1450 brooks road; memphis, tennessee; memphis 38116
• MDR Report Key: 7958359
• MDR Text Key: 123502135
• Report Number: 1020279-2018-02119
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 03596010557285
• UDI-Public: 03596010557285
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/04/2018

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 Catalogue Number: 74018901
• Device Lot Number: 13FST0009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• Initial Date Manufacturer Received: 09/18/2018
• Initial Date FDA Received: 10/11/2018
• Supplement Dates Manufacturer Received: 09/18/2018
• Supplement Dates FDA Received: 12/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1