MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIBINRT S3-4LM/RL8MM; PROSTHE, KNEE, FEMOROT, NON-CONS, CEMENTED, METAL/POLY

Model Number 71422251

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 02/14/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference number: (b)(4).

Event Description

It was reported that, after a thr on (b)(6) 2013, the journey uni tibinrt s3-4lm/rl8mm dislocated at some point in the last month.A revision surgery was performed on (b)(6)2022 to solved this adverse event.The current health status of patient is unknown.

Manufacturer Narrative

Section h3, h6: the associated device was returned and evaluated.A visual inspection of the returned device did not confirm the stated failure mode.The was found to be severely worn from prolonged use.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.The clinical/medical evaluation concluded that the requested medical documentation has not been received as of the date of the medical investigation and it is unknown if the patient experienced any trauma prior to the reported event.Without the requested clinical documentation, the root cause of the reported insert dislocation could not be further assessed.The patient impact beyond the reported dislocation and revision/conversion to a ps tka could not be determined.No further medical assessment could 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.The contribution of the device to the reported event could not be corroborated.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.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: JOURNEY UNI TIBINRT S3-4LM/RL8MM
• Type of Device: PROSTHE, KNEE, FEMOROT, NON-CONS, CEMENTED, METAL/POLY
• 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: 14412103
• MDR Text Key: 291813893
• Report Number: 1020279-2022-02383
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 03596010582126
• UDI-Public: 03596010582126
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/17/2022

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: Lay User/Patient
• Device Model Number: 71422251
• Device Catalogue Number: 71422251
• Device Lot Number: 21DM09230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2022
• Initial Date FDA Received: 05/16/2022
• Supplement Dates Manufacturer Received: 06/16/2022
• Supplement Dates FDA Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2021
• 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: UNKN JOURNEY UNI KNEE FEM COMP; UNKN JOURNEY UNI KNEE TIB BASEPLATE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male