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

Model Number 71440192

Device Problems Material Fragmentation (1261); Naturally Worn (2988)

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

Event Date 02/01/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).Results of investigation: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device was found to be worn along the impactor face, rendering the device inoperative.The device shows signs of extensive use.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 that per complaint details, the consigned impactors were leaving ¿black bits¿ in a ¿very few¿ number of patients due to wear and tear.Reportedly, ¿a through washout was performed¿ and ¿no pieces of black plastic have been left inside any patients and no harm has come to any of the patients¿.The requested operative notes were reportedly unavailable.Per the cleaning, sterilization and maintenance brochure [01004_v2], end of (product) life is normally determined by wear and damage due to use, and all reusable devices should be visually inspected for damage or wear and discarded.As reported, the event was due to ¿wear and tear¿.The impact to the patients beyond that which was reported would not be anticipated as it was reported that ¿no pieces.Have been left inside any patients and no harm¿ resulted.No further medical assessment is warranted 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.A contribution of the device to the reported event could be corroborated as the device shows signs of damage/wear.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.

Event Description

It was reported that, during tka surgery, the genesis ii tibial baseplate impactor is leaving black bits in the patient during use, due to wear and tear.A thorough washout was performed to avoid any bits being left in the patient.Surgery was performed, without any delay, with the same device.Patient was not harmed as consequence of this problem.

• 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
• 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: 14246271
• MDR Text Key: 290372372
• Report Number: 1020279-2022-02039
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010214386
• UDI-Public: 03596010214386
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2012
• Device Model Number: 71440192
• Device Catalogue Number: 71440192
• Device Lot Number: 02HM02884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention