MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTICULAR SURFACE SIZE 6 8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 00584202608

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/26/2018

Event Type  malfunction  

Event Description

It was reported that during surgery, trial split in 2 pieces.There was no delay, no injury, no backup device available, had to divert from original procedure.

Manufacturer Narrative

The affected articular surface provisional was not returned for evaluation.Without the return of the actual product involved and no batch information available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: ARTICULAR SURFACE SIZE 6 8MM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8172022
• MDR Text Key: 130623579
• Report Number: 1020279-2018-02814
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00885556620274
• UDI-Public: 00885556620274
• Combination Product (y/n): N
• PMA/PMN Number: K033363
• 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: 02/22/2019

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: 00584202608
• Initial Date Manufacturer Received: 11/26/2018
• Initial Date FDA Received: 12/17/2018
• Supplement Dates Manufacturer Received: 11/26/2018
• Supplement Dates FDA Received: 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1