MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JUNI OX FB FEM SZ 4 RM LL; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71422354

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 10/06/2015

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after a right uka surgery performed in (b)(6) 2013, the patient experienced unexplained pain.This event was addressed via revision surgery on (b)(6) 2015 to explant the femoral and tibial components.Patient health status is not known.This information was provided by the national joint registry of the united kingdom, as part of a retrospective data collection of patients who underwent a revision surgery of journey uni prothesis.As such, no further information will be available.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, a right revision was performed approximately 2 years post uka due to unexplained pain.The patient body mass index (bmi) is documented as 45; however, as of the date of this medical investigation, the requested clinical documentation has not been provided as the information was provided by the national joint registry of the united kingdom as part of a retrospective data collection, and reportedly, no further information will be available.Although the jii-uni surgical technique lists contraindications that tend to place increased loads on implants (such as age, weight, activity level, etc¿) it is unknown if the patient¿s bmi was a contributing factor to the reported event based on the limited information provided and it cannot be concluded that there was a malperformance of the component(s).The patient outcome beyond that which was reported could not be confirmed nor concluded; therefore, 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.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 documents for knee systems revealed that improper fixation, and/or migration of the components could cause possible adverse effects.Besides, it establish that the implant can become damaged as a result of strenuous activity or trauma.The patient should be warned of surgical risks, and made aware of possible adverse effects, this has been identified as a warnings and precautions.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.Possible causes could include but not limited to traumatic injury, joint tightness, material in use, patient reaction or loss of sterility.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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: JUNI OX FB FEM SZ 4 RM LL
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-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, TX 78735 ; 5123913905
• MDR Report Key: 15375167
• MDR Text Key: 299444515
• Report Number: 1020279-2022-04002
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 03596010627407
• UDI-Public: 03596010627407
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K073175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2023
• Device Model Number: 71422354
• Device Catalogue Number: 71422354
• Device Lot Number: 13DM05712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/08/2022
• Date Device Manufactured: 04/08/2013
• 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
• Treatment: JRNYUNI APTIBSZ3RM/LL7MM, LOT#:10DM06250
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 110 KG