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

Catalog Number UNKN01200322

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

Patient Problems Unspecified Infection (1930); Laceration(s) (1946); Joint Laxity (4526)

Event Date 05/10/2020

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.Mergenthaler, g, et al.(2020).Is robotic-assisted unicompartmental knee arthroplasty a safe procedure? a case control study.Knee surgery, sports traumatology, arthroscopy (vol.29, pag 931-938).Doi: 10.1007/s00167-020-06051-z.(b)(4).

Event Description

It was reported that, on the literature review "is robotic-assisted unicompartmental knee arthroplasty a safe procedure? a case control study", a total of two hundred (200) ukas were conducted and assisted with a a blue belt navio robotic surgical system.From this cohort, a total of thirteen (13) reoperations were required after an unknown postoperative period following the index uka procedure.From these, nine (9) patients underwent an arthrolysis procedure, two (2) patients underwent a debridement with antibiotics (implant retention) and two (2) patients underwent an arthroscopy procedure for contralateral meniscal tear and loose body.The specific uka implants associated to each patient could not be confirmed at this time, as the paper states that all implants were cemented and consisted of either an all polyethilene tibial component and resurfacing femoral component (hls-uni evolution, tornier) or a metal backed tibial component with conventional femoral component (journey uni, smith & nephew).The outcome of all patients is unknown.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

The devices were not returned for evaluation and the reported events could not be confirmed.The clinical/medical investigation concluded that, per the complaint details, a retrospective cohort study of the npvio¿-assisted uka noted thirteen (13) reoperations (table l3): nine (9) patients underwent an arthrolysis procedure, two (2) patients underwent a debridement with antibiotics (implant retention) and two (2) patients underwent an arthroscopy procedure for contralateral meniscal tear and loose body.The specific uka implants associated to each patient could not be confirmed at this time, as both s+n and competitor components were involved in the study.The outcome of all patients is unknown.As of the date of this medical investigation, clinical documentation has not been received.Without patient specific medical documentation, definitive clinical factors which could have contributed to the reported events noted in table 3 could not be concluded.The impact to each patient beyond that which was reported cannot be determined based on the limited information provided in the literature.No further medical assessment can be rendered 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 excessive pressure on the joint, injury, surgical/post operative complications, healing issues, patient condition, and/or patient reaction.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.Internal complaint reference number: case (b)(4).

• Brand Name: UNKN JOURNEY UNI KNEE FEM COMP
• 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: 15269779
• MDR Text Key: 298380060
• Report Number: 1020279-2022-03782
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01200322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/16/2022
• 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: (B)(6)/NAVIO SURGICAL SYSTEM BE/FR/DE
• Patient Outcome(s): Other