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 Problem Material Integrity Problem (2978)

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

Event Date 05/03/2018

Event Type  malfunction  

Event Description

Cam arm covers came off cam arms.All pieces accounted for.Backup device was used, no delay to procedure, no injury to patient.Device is being returned.

Manufacturer Narrative

The associated bcs ii locking femoral implant impactor was returned and evaluated.Visual inspection of the product showed a fracture through the anterior cam bumper, which was likely due to overload.An overload fracture can occur when the mechanical forces applied to the instrument exceed the strength of the material.The broken piece is returned.The device was manufactured in 2017.A review of complaint history on the listed part revealed no additional complaints for this failure mode with the same batch number.Our investigation included a review of the manufacturing records for the listed batch which did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.We consider this investigation closed.Should the device or additional information be received, the complaint will be reopened.

• 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 ; 101 hessle road; hull hu3 2bn; UK
• MDR Report Key: 7547828
• MDR Text Key: 109363991
• Report Number: 1020279-2018-01013
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/03/2018

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: Physician
• Device Catalogue Number: 74012812
• Device Lot Number: 17KSM0292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2018
• Initial Date FDA Received: 05/28/2018
• Supplement Dates Manufacturer Received: 05/03/2018
• Supplement Dates FDA Received: 06/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1