MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN AP FEM CUTTING BLK SZ 4; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 71434409

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2018

Event Type  malfunction  

Event Description

It was reported that during surgery the ball bearings that hold the valves collett in place came loose.Device broke in patient, all pieces accounted for.No delay or injury reported.No back up required, device use had been completed.

Manufacturer Narrative

The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.Both ball plungers disassembled from the device and only one was returned with the device.The device was manufactured in 2017 and exhibits signs of moderate wear/usage.A dimensional inspection was performed and an out of tolerance feature was found that could have contributed to the failure.Corrective action is being addressed by the internal quality hold process.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.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: LGN AP FEM CUTTING BLK SZ 4
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8201038
• MDR Text Key: 131586622
• Report Number: 1020279-2018-02929
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010549174
• UDI-Public: 03596010549174
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71434409
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1