MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK ATTUNE FEMORAL; KNEE IMPLANTS - FEMORAL

Catalog Number UNK ATTUNE FEMORAL

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

Patient Problems Pulmonary Embolism (1498); Loss of Range of Motion (2032); Joint Laxity (4526); Joint Contracture (4528); Unspecified Tissue Injury (4559)

Event Date 02/12/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.H6 component code: appropriate term/code not available (g07002) used to capture no findings available.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: wendelspiess s, kaelin r, vogel n, rychen t, arnold mp.No difference in patient-reported satisfaction after 12 months between customised individually made and off-the-shelf total knee arthroplasty.Knee surg sports traumatol arthrosc.2022 sep;30(9):2948-2957.Doi: 10.1007/s00167-022-06900-z.Epub 2022 feb 12.Pmid: 35149877; pmcid: pmc9418302.Objective and methods: the aim of this study was to compare outcomes and satisfaction of patients with 74 competitor custom made tka constructs (cim) and 169 depuy attune off-the-shelf (ots) tka constructs implanted between january 2017 and september 2020.As the cim constructs were all competitor products, this complaint will capture the results for the 169 depuy attune cruciate retaining mobile-bearing tkas.The manufacturer of the cement utilized with the attune tkas is unknown.The authors note that an unspecified amount of patellas were resurfaced when there was severe patella-femoral arthritis.Lot, model and catalog number are not available, but the suspected depuy device possibly associated with reported adverse events: attune cruciate-retaining, mobile bearing tka including a femoral component, tibial insert, tibial tray, and patella.Adverse event(s) and provided interventions associated with depuy devices: 1 death.There is insufficient information to determine if the death is related to the devices and/or procedure.In a postoperative survey, the surgeons reported an unknown number of post-operative instability, decreased rom, and flexion contractures- treatment unknown.1 quadriceps tendon rupture- treatment not specified.2 complete revisions for unknown reasons.2 additional surgical procedures to resurface the patellas for unspecified reasons.I pulmonary embolism- treatment unspecified.

• Brand Name: UNK ATTUNE FEMORAL
• Type of Device: KNEE IMPLANTS - FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND - 9616671; loughbeg, ringaskiddy co; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16822961
• MDR Text Key: 314086386
• Report Number: 1818910-2023-08825
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/27/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK ATTUNE FEMORAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2023
• Initial Date FDA Received: 04/27/2023
• 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
• Patient Outcome(s): Required Intervention