MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 5-6 RT 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 74027252

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problem Discomfort (2330)

Event Date 11/20/2023

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference: case (b)(4).

Event Description

It was reported that, after a tka surgery had been performed on (b)(6) 2020, the patient experienced a grinding sensation.This adverse event was treated by a revision surgery, on (b)(6)b 2023, in which a cement particle was found in between the femoral component and the poly, debridement, lateral release and a poly exchange was performed.Current health status of patient is unknown.

Manufacturer Narrative

Medical device problem code: updated.H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation stated that, according to the reported revision surgery findings, there were cement particles found between the femoral component and the poly, therefore a procedural variance cannot be ruled out.Since the patient¿s outcome is unknown, the impact to the patient beyond the reported grinding sensation, the subsequent revision, and the expected transient recovery period cannot be determined.Further impact can only be presumed but regularly scheduled follow-up/monitoring would be anticipated.Therefore, no further clinical/medical assessment is warranted at this time.A review of the instructions for use documents for knee systems revealed that prior to closure, the surgical site should be thoroughly cleaned of bone chips, extraneous cement, ectopic bone, etc.Foreign particles at the metal and/or plastic interface may cause excessive wear and/or friction.This has been identified as a warning and precaution.Based on the information provided, the patient discomfort was caused by the cement particles between the femoral component and the poly, therefore the unsatisfactory experience could be confirmed.Factors that could contribute to the reported event include surgical technique used or user/procedural variance.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 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.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 specifications at the time of manufacture.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 closed.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation stated that, according to the reported revision surgery findings, there were cement particles found between the femoral component and the poly, therefore a procedural variance cannot be ruled out.Since the patient¿s outcome is unknown, the impact to the patient beyond the reported grinding sensation, the subsequent revision, and the expected transient recovery period cannot be determined.Further impact can only be presumed but regularly scheduled follow-up/monitoring would be anticipated.Therefore, no further clinical/medical assessment is warranted at this time.A review of the instructions for use documents for knee systems revealed that prior to closure, the surgical site should be thoroughly cleaned of bone chips, extraneous cement, ectopic bone, etc.Foreign particles at the metal and/or plastic interface may cause excessive wear and/or friction.This has been identified as a warning and precaution.Based on the information provided, the patient discomfort was caused by the cement particles between the femoral component and the poly, therefore the unsatisfactory experience could be confirmed.Factors that could contribute to the reported event include surgical technique used or user/procedural variance.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 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.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 specifications at the time of manufacture.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 closed.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 5-6 RT 10MM
• 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: 18302475
• MDR Text Key: 330180689
• Report Number: 1020279-2023-02464
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556179413
• UDI-Public: 00885556179413
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111711
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2024

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 Catalogue Number: 74027252
• Device Lot Number: 16KM13954
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/11/2023
• Supplement Dates Manufacturer Received: 01/16/2024; 01/25/2024
• Supplement Dates FDA Received: 01/17/2024; 01/30/2024
• Date Device Manufactured: 10/21/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Other