MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK ATTUNE FEMORAL

Catalog Number UNK ATTUNE FEMORAL

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Date 02/01/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint: (b)(4).The device catalog number is unknown; therefore, udi is unavailable.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.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.

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: koster la, rassir r, kaptein bl, sierevelt in, schager m, nelissen rghh, nolte pa.A randomized controlled trial comparing two-year postoperative femoral and tibial migration of a new and an established cementless rotating platform total knee arthroplasty.Bone joint j.2023 feb;105-b(2):148-157.Doi: 10.1302/0301-620x.105b2.Bjj-2022-0414.R1.Pmid: 36722052.Objective and methods: the primary aim of this study was to compare the migration of the femoral and tibial components of the cementless rotating platform attune and low contact stress (lcs) total knee arthroplasty (tka) designs, two years postoperatively, using radiostereometric analysis (rsa) in order to assess the risk of the development of aseptic loosening.A secondary aim was to compare clinical and patient-reported outcome measures (proms) between the designs.A total of 62 tkas (24 attune and 28 lcs) implanted between july 2017 and march were analyzed.No patellas were resurfaced.Lot, model and catalog number are not available, but the suspected depuy device possibly associated with reported adverse events: lcs or attune cementless rp constructs including femoral component, tibial insert, and tibial tray adverse event(s) and provided interventions associated with depuy devices: an unknown number of attune and lcs tibial and femoral components were identified as migrated on serial radiographic studies.No treatment provided.An unknown number of patients reported postoperative pain, no treatment provided.1 patient with preexisting valgus deformity received an attune tibial insert revision to treat spin out.

• Brand Name: UNK ATTUNE FEMORAL
• Type of Device: ATTUNE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16724274
• MDR Text Key: 313540490
• Report Number: 1818910-2023-07784
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 03/28/2023
• Initial Date FDA Received: 04/12/2023
• 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