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

Catalog Number UNKNOWN

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

Patient Problems Unspecified Infection (1930); Arthralgia (2355); Deformity/ Disfigurement (2360); Inadequate Osseointegration (2646)

Event Date 05/05/2022

Event Type  Injury  

Event Description

It was reported that, according to data obtained from the australian orthopaedic association national joint replacement registry (aoanjrr), a total of 340 primary unicompartmental knee replacement procedures with the journey uni all poly system were studied in a period between 1-sep-1999 and 4-may-2022.From this cohort, 40 patients required a revision surgery due to different reasons, including loosening (17 patients), progression of disease (13 patients), pain (3 patients), infection (3 patients), lysis (3 patients), and malalignment (1 patient).From the 40 revised patients, 39 had a tkr (tibial/femoral) revision and 1 had a uni tibial component only revision.The patients that suffered from the revision surgery had the following primary components implanted: journey uni tibial all poly baseplate jrnyuni aptibs1rm/ll8mm (2 patients), rnyuni aptibs2rm/ll9mm (2 patients), jrnyuni aptibs3lm/rl8mm (1 patients), jrnyuni aptibs3rm/ll8mm (3 patients), jrnyuni aptibs4lm/rl8mm (2 patients), jrnyuni aptibs4lm/rl9mm (3 patients), jrnyuni aptibs4rm/ll8mm (1 patient), jrnyuni aptib s4rm/ll9mm (2 patients), jrnyuni aptibs5lm/rl8mm (2 patients), jrnyuni aptibs5rm/ll8mm (2 patients), jrnyuni aptibs5rm/ll10mm (1 patient), jrnyuni aptibs6lm/rl8mm (1 patient), jrnyuni aptibsz1lm/rl7mm (1 patient), jrnyuni aptibsz3lm/rl7mm (2 patients), jrnyuni aptibsz4lm/rl7mm (3 patients), jrnyuni aptibsz6lm/rl7mm (2 patients), jrnyuni aptibsz2rm/ll7mm (1 patient), jrnyuni aptibsz3rm/ll7mm (1 patient), jrnyuni aptibsz4rm/ll7mm (5 patients), jrnyuni aptibsz5rm/ll7mm (1 patient) and jrnyuni aptibsz6rm/ll7mm (2 patients).Journey uni femoral component oxinium juni ox fb fem sz 1 lm rl (1 patient), juni ox fb fem sz 3 lm rl (5 patients), juni ox fb fem sz 4 lm rl (4 patients), juni ox fb fem sz 5 lm rl (2 patients), juni ox fb fem sz 6 lm rl (4 patients), juni ox fb fem sz 7 lm rl (1 patient), juni ox fb fem sz 2 rm ll (2 patients), juni ox fb fem sz 3 rm ll (7 patients), uni ox fb fem sz 4 rm ll (5 patients), juni ox fb fem sz 5 rm ll (5 patients), juni ox fb fem sz 6 rm ll (3 patients), and juni ox fb fem sz 7 rm ll (1 patient).As the information was extracted from the aoanjrr, no further information is available.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6: the devices were not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the data presented was obtained from the australian orthopedic association national joint replacement registry (aoanjrr) was reviewed.Per the complaint, no further information will not be provided.Consequently, without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The images and/or graphs provided in the article have been interpreted within the text; therefore, no further analysis of the images and/or graphs is required.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.At this time, we have no reason to suspect that the products 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 abnormal motion over time, abnormal loading of limb, bone degeneration, patient reaction, patient anatomy, post-operative healing issue, fit/sizing issue, lack of ingrowth, lifetime of device, joint tightness, material in use, loss of sterility, contamination, surgical technique used, user/procedural variance and/or traumatic injury.The contribution of the devices 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 products involved, our investigation could not proceed.Should the devices 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: JOURNEY UNI KNEE IMPL
• 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: 15053711
• MDR Text Key: 296153268
• Report Number: 1020279-2022-03331
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/11/2022
• 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: UNKNOWN JOURNEY UNI KNEE FEMORAL COMPONENT OXINIUM; UNKNOWN JOURNEY UNI KNEE TIBIAL BASEPLATE ALL POLY
• Patient Outcome(s): Required Intervention; Hospitalization