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

Model Number 71440005

Device Problem Fracture (1260)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Fibrosis (3167)

Event Date 12/19/2022

Event Type  Injury  

Manufacturer Narrative

Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.(b)(4).

Event Description

It was reported that during a tka surgery was performed apparently the ps implant impactor broke a small threaded piece off of the thumb screw that remained in the posterior aspect of the joint.The fragment was confirmed radiographically.This adverse event was treated by a revision surgery on (b)(6) 2022 to remove the piece.The patient current health status is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation.However, the photographs were reviewed, and revealed that the positive lock bolt is broken.The clinical/medical investigation concluded that, based on the information provided, the patient¿s non-compliance with the rehab plan, the reported pain, stiffness, arthrofibrosis, and swelling, in addition to the retained foreign body midline posterior to the right knee, confirmed by an x-ray report dated 12-8-2022, were likely contributory factors that led to the subsequent revision.According to the report, the retained foreign body does not appear to be associated with the prosthetic components.Per report, the patient was counseled by the surgeon at length on the importance of increasing her range of emotion to prevent an additional manipulation under anesthesia.However, the definitive clinical root cause of the reported events nor a causal relationship between the smith and nephew device can be confirmed.The impact to the patient beyond the reported revision with the polyethylene exchange, the foreign body removal, and the continued arthrofibrosis cannot be determined.The explanted poly was not returned for evaluation.Therefore, no further clinical/medical assessment can be rendered at this time.Should any additional relevant medical information be provided, this case would be re-assessed.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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.A review of the instructions for use file is not applicable for this instrument.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.With the results of this investigation the root cause of this event could not be determined.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to 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 the device or 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.

Manufacturer Narrative

H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device reveals a piece of the positive lock bolt broke off.The broken piece was not returned.The device exhibit signs of significant wear and use.The clinical/medical investigation concluded that, based on the information provided, the patient¿s non-compliance with the rehab plan, the reported pain, stiffness, arthrofibrosis, and swelling, in addition to the retained foreign body midline posterior to the right knee, confirmed by an x-ray report dated (b)(6) 2022, were likely contributory factors that led to the subsequent revision.According to the report, the retained foreign body does not appear to be associated with the prosthetic components.Per report, the patient was counseled by the surgeon at length on the importance of increasing her range of emotion to prevent an additional manipulation under anesthesia.However, the definitive clinical root cause of the reported events nor a causal relationship between the smith and nephew device can be confirmed.The impact to the patient beyond the reported revision with the polyethylene exchange, the foreign body removal, and the continued arthrofibrosis cannot be determined.The explanted poly was not returned for evaluation.Therefore, no further clinical/medical assessment can be rendered at this time.Should any additional relevant medical information be provided, this case would be re-assessed.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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.A review of instructions for use for care, maintenance, cleaning and sterilization of smith & nephew orthopedics devices revealed that visually inspecting for damage or wear, including components in their disassembled state prior to re-assembly as well as ensuring components are re-assembled securely is indicated.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.With the results of this investigation the root cause of this event could not be determined.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to 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: FEMORAL IMPLANT 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: 16184129
• MDR Text Key: 307487488
• Report Number: 1020279-2023-00108
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 00885556034156
• UDI-Public: 00885556034156
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/30/2023

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: 71440005
• Device Catalogue Number: 71440005
• Device Lot Number: 18ASM1180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/20/2022
• Initial Date FDA Received: 01/17/2023
• Supplement Dates Manufacturer Received: 02/03/2023; 03/23/2023
• Supplement Dates FDA Received: 02/07/2023; 03/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female