MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN JOURNEY UNI KNEE TIB BASEPLATE; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNKN01200325

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Pain (1994); Inadequate Osseointegration (2646)

Event Date 02/22/2022

Event Type  Injury  

Manufacturer Narrative

Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.(b)(4).

Event Description

On the literature review " combined procedures with unicompartmental knee arthroplasty: high risk of stiffness but promising concept in selected indications", it was reported that, after undergoing a navio-assisted uka procedure using journey ii uni system, one (1) patient experienced pain and aseptic loosening of the tibial component.These event was treated with a revision surgery to tka.No further information is available.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Section h10: given the nature of the alleged incident, the device, could not be returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per the complaint details, a navio-assisted uni-knee study patient (sited from a retrospective analysis literature review) was treated with a revision surgery (uni to tka) due to pain and aseptic loosening of the tibial component.As of the date of this medical investigation, the requested clinical documentation has not been received.Reportedly, no further information is available.The author has provided radiological assessment of the imaging within the text; therefore, further analysis is not warranted.Without the requested medical documentation, definitive clinical factors which could have contributed to the reported event could not be concluded.The patient outcome beyond that which was reported could not be determined.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as joint tightness, patient reaction, postoperative care, abnormal motion over time, bone degeneration, size selected, osteolysis and/or traumatic injury.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.Internal complaint reference number: (b)(4) section h6 (clinical code) was corrected.

• Brand Name: UNKN JOURNEY UNI KNEE TIB BASEPLATE
• 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: 15254905
• MDR Text Key: 298196188
• Report Number: 1020279-2022-03752
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01200325
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: No
• 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 INSERT; UNKN NAVIO ROBOTICS SYSTEM
• Patient Outcome(s): Other