MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GENESIS II SPC F/E SZ GDE; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71933043

Device Problems Break (1069); Nonstandard Device (1420)

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

Event Date 09/09/2020

Event Type  malfunction  

Event Description

It was reported that, during surgery, the genesis ii spc f/e sz gde was found broken: the rod would not attach properly.The procedure was completed with the same device.Surgery was not delayed.The patient was not harmed.On investigation results it was found that the connecting feature was oversize on the device.

Manufacturer Narrative

The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.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.The dimensional evaluation confirmed the stated failure mode.The connecting feature was found to be oversize on the device, so (b)(4) was initiated and assigned to supplier quality for further investigation.At this time, we have reason to suspect that the product failed to meet product specifications at the time of manufacture.A potential probable cause could be but is not limited to a manufacturing deficiency.Based on this investigation, the need for corrective action is indicated.Should additional information be received, the complaint will be reopened.This is an isolated event that is currently being monitored.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.

Manufacturer Narrative

The associated device was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The dimensional evaluation confirmed the stated failure mode.The connecting feature was found to be oversize on the device.A review of complaint history based on the historical data revealed similar events for the listed batch, this failure mode will be monitored for future complaints 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 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 was found to be out of tolerance per dimensional specification, the contribution of the device to the reported event could be corroborated.A potential probable cause could be but is not limited to a manufacturing deficiency.Based on this investigation, the need for corrective action is indicated.The event is being addressed through the supplier quality team.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.

• Brand Name: GENESIS II SPC F/E SZ GDE
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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; austin, TX 78735 ; 5123913905
• MDR Report Key: 12800899
• MDR Text Key: 284185284
• Report Number: 1020279-2021-08103
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 00885556059951
• UDI-Public: 00885556059951
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71933043
• Device Catalogue Number: 71933043
• Device Lot Number: 17KCT0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/31/2017
• 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