MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII CR DEEP FLEX ISRT S3-4 9M; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number 71421536

Device Problem Material Erosion (1214)

Patient Problem Failure of Implant (1924)

Event Date 06/28/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after a tka surgery had been performed in 2007, the gii cr deep flex isrt s3-4 9m worn through on medial side.The adverse event was addressed with a revision surgery on (b)(6) 2022 to replace the device.The patient's current health status is unknown.

Manufacturer Narrative

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 medial side of the device.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.The clinical/medical evaluation concluded that based on the documentation provided, the clinical root cause of component wear could not be definitively concluded.Additionally, it is unknown if the patient¿s body habitus/obesity, 3rd body wear with length of time in-vivo (15 years) and/or trauma contributed to the reported events.The date of symptom onset is unknown.The patient impact beyond that which was reported along with the revision could not be determined.The patient status was reportedly ¿unknown but recovering from femoral component revision to ps with ps poly implanted on existing tibial component¿.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 and instructions for use document 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.Wear potential causes could include but are not limited to friction, joint tightness, patient¿s body habitus and trauma, or lifetime of device.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.

• Brand Name: GII CR DEEP FLEX ISRT S3-4 9M
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/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: 15072242
• MDR Text Key: 296287986
• Report Number: 1020279-2022-03356
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 03596010512444
• UDI-Public: 03596010512444
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/27/2016
• Device Model Number: 71421536
• Device Catalogue Number: 71421536
• Device Lot Number: 06LM14289
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female