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

Model Number 74012812

Device Problem Flaked (1246)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2021

Event Type  Injury  

Event Description

It was reported that, during a tka surgery, one of the mechanical arms of a jrn ii bcs lck fem implant impact chipped.This was noticed after the case, but all pieces were recovered, so nothing had fallen inside of the patient.Surgery had been completed, without any delay, with the same device.Patient was not harmed as consequence of this problem.

Manufacturer Narrative

The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device was chipped along one of the mechanical arms, rendering the device inoperative.The device shows signs of extensive use.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.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 do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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 is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: JRN II BCS LCK FEM IMPLANT IMPACT
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12118819
• MDR Text Key: 260107058
• Report Number: 1020279-2021-05697
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556003541
• UDI-Public: 00885556003541
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 74012812
• Device Catalogue Number: 74012812
• Device Lot Number: 14HST0002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Initial Date Manufacturer Received: 06/21/2021
• Initial Date FDA Received: 07/05/2021
• Supplement Dates Manufacturer Received: 08/19/2021
• Supplement Dates FDA Received: 08/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention