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

Model Number 74026024

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

Patient Problem Inadequate Osseointegration (2646)

Event Type  Injury  

Event Description

It was reported that, after a left medial unicompartmental knee replacement had been performed on an unspecified date to address a medial gonarthrosis symptoms, the patient required a revision surgery on an unknown date due to the loosening of the implants.According to the data set provided, this event occurred eighty-one (81) days following the index implantation.The outcome of this patient is unknown.This incident was noticed in a retrospective post-market clinical follow up activity (pmcf) where anonymized data summarizing outcomes were gathered retrospectively; therefore, additional information is not known.

Manufacturer Narrative

Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a patient complication identified through the review of clinical evidence from post market clinical data collection activities that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.

Manufacturer Narrative

D1: brand name, d4: catalog number and unique identifier (udi) # , d11: concomitant medical products and therapy dates and g5: 510(k) #.

• Brand Name: JUNI COCR FB FEM SZ 4 LM RL
• 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: 16545868
• MDR Text Key: 311318086
• Report Number: 1020279-2023-00532
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 03596010627476
• UDI-Public: 03596010627476
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K073175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 74026024
• Device Catalogue Number: 71422364
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: JOURNEY II UK MED TIB BASE SZ 3 LT; JOURNEY II UK TIB INSRT MED SZ 3-4 8MM; JOURNEY UNI TIBINRT S3-4LM/RL8MM; JRNY UNI TIBIAL BASE LM/RL SZ 3
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female