MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR LKG FEM IMP BUMPER LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLY/M/POLY

Model Number 74011856

Device Problems Break (1069); Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/22/2020

Event Type  malfunction  

Event Description

It was reported that the bumper snapped in half while being impacted, but pieces did not fall into the patient.An s&n backup was available.Surgery was not delayed.The patient was not harmed.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.The clinical/medical team concluded, per complaint details, the ¿bumper snapped in half¿ while being impacted; however, ¿nothing fell into the patient¿.Reportedly, the procedure was completed using a backup s+n device without delay and no patient injury/harm resulted from the event.Patient impact beyond the modified surgical procedure/use of the backup device would not be anticipated as the procedure was reportedly completed without patient harm, and/or surgical delay; therefore, since no patient injury/harm was alleged, no further medical assessment is warranted at this time.A visual inspection confirmed the jrny ii cr lkg fem imp bumper lt is broken in two pieces.The device shows significant signs of wear/usage.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.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.

• Brand Name: JRNY II CR LKG FEM IMP BUMPER LT
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLY/M/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10428735
• MDR Text Key: 203625220
• Report Number: 1020279-2020-04074
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556422878
• UDI-Public: 00885556422878
• Combination Product (y/n): N
• PMA/PMN Number: K121443
• 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: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 74011856
• Device Catalogue Number: 74011856
• Device Lot Number: 12FBG0002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Date Manufacturer Received: 11/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1