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

Model Number	71422251
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1020279-2022-02383
• Device Sequence Number: 14837426
• Product Code: HSX
• UDI-Device Identifier: 03596010582126
• UDI-Public: 03596010582126
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K061011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2022
• Supplement Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 05/16/2022
• Supplement Report FDA Received Date: 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKN JOURNEY UNI KNEE FEM COMP; UNKN JOURNEY UNI KNEE TIB BASEPLATE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male