MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRN BCS II LCK FEM IMPLANT IMPACT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 74012812

Device Problems Device Damaged by Another Device (2915); Material Integrity Problem (2978)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 10/01/2018

Event Type  malfunction  

Event Description

It was reported that a malfunction has occurred during surgery.The plastic was chipping off of impactor.

Manufacturer Narrative

The affected device was returned and evaluated.A visual inspection of the femoral implant impact confirmed the complaint that the anterior cam bumper has begun to chip off; the missing pieces were not returned.Additionally, the instrument exhibits moderate use damage on the impactor bumpers.We recommend that all reusable instruments be routinely inspected for wear and damage so they can be replaced as necessary.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Based on this investigation, the need for corrective action is not indicated.No additional actions are being taken at this time; however we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: JRN BCS II LCK FEM IMPLANT IMPACT
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 8000159
• MDR Text Key: 124843414
• Report Number: 1020279-2018-02234
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556003541
• UDI-Public: 00885556003541
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111711
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/04/2019

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: 74012812
• Device Lot Number: 17ATD0004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2018
• Initial Date FDA Received: 10/24/2018
• Supplement Dates Manufacturer Received: 10/01/2018
• Supplement Dates FDA Received: 01/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1