MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII TIBIAL BASE IMPACTOR; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number 71440192

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/05/2020

Event Type  Injury  

Event Description

It was reported that during tka procedure the gii tibial base impactor got damaged while impacting the tibial component.Part of the plastic was chunking off due to the impactor hitting the tibial baseplate.Baseplate was implanted successfully.There was no delay, and procedure concluded with the same device.No injuries or other complications were reported at this time.

Manufacturer Narrative

H3: h6: the device used in treatment was not returned for evaluation.Without the actual product, product evaluation could not be performed and complaint could not be confirmed.The device was manufactured in 2016.According to clinical/medical investigation, the plastic bottom of the impactor was ¿chunking off¿ during impaction; however, the baseplate was implanted successfully without delay, with the same device, and no foreign body was left in patient.Reportedly, there was ¿no impact to patient, patient outcome is fine¿.It was communicated that the requested medical documentation would not be provided for inclusion in the medical investigation.No patient injury or surgical delay is being alleged; therefore, no further medical assessment is warranted at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device is a reusable device that can be exposed to numerous surgeries and cleaning cycles.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further actions are being taken at this time.We consider this investigation closed.Credit will not be issued for the device.

• Brand Name: GII TIBIAL BASE IMPACTOR
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10737909
• MDR Text Key: 213149126
• Report Number: 1020279-2020-05765
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010214386
• UDI-Public: 03596010214386
• Combination Product (y/n): N
• 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: 02/11/2021

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: 71440192
• Device Catalogue Number: 71440192
• Device Lot Number: 18CM03085
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/05/2020
• Initial Date FDA Received: 10/26/2020
• Supplement Dates Manufacturer Received: 02/10/2021
• Supplement Dates FDA Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention