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

Model Number 71440190

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

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

Event Date 08/10/2022

Event Type  malfunction  

Event Description

It was reported that, during a tka, one (1) gii femoral impactor detached from handle.It is unknown how the procedure finish, however a significant delay (more than 30 minutes) was reported.Patient was not injured as consequence of this problem.

Manufacturer Narrative

Internal complaint reference (b)(4).

Manufacturer Narrative

Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The head of the impactor fractured off from the rest of the device, rendering the device inoperative.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.The clinical/medical evaluation concluded as such: this case reports the gii femoral impactor detached from handle during use internal to the patient.It is unknown if any fragments were left inside of the patient.No clinically relevant supporting documentation was provided for inclusion in this medical investigation.Therefore, the root cause of the reported gii femoral impactor handle detachment could not be determined.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.The gii femoral impactors are manufactured and intended as externally communicating devices and are not approved for long term internal tissue exposure and long-term implantation data is not available.According to the report, it is unknown how the procedure was completed, however, a significant delay of greater than 30-minutes was reported.Although, it was reported the patient was not injured because of this issue, the patient impact beyond possibility of retained non-implantable fragments, micro-motion and/or migration, and local irritation/discomfort cannot be determined.However, we cannot make conclusions on the impact of the non-implantable foreign body to the patient.Therefore, no further medical assessment can be rendered at this time.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.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.As the device broke and it can no longer fit its purpose, the contribution of the device to the reported event could be corroborated.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 future complaints and investigate as necessary.We consider this investigation closed.Corrected data: b1, h1, h3, h6 (medical device problem code).

• Brand Name: GII FEMORAL IMPACTOR
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15317182
• MDR Text Key: 298859375
• Report Number: 1020279-2022-03887
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010214379
• UDI-Public: 03596010214379
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71440190
• Device Catalogue Number: 71440190
• Device Lot Number: 11DM05523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2011
• 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
• Patient Outcome(s): Required Intervention