MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK ALIGNMENT DEVICE

Catalog Number UNK ALIGNMENT DEVICE

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

Patient Problem Bone Fracture(s) (1870)

Event Date 02/11/2021

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: mahmoud k, metikala s, o'connor km, farber dc.Adverse events related to total ankle replacement devices: an analysis of reports to the united states food and drug administration.Int orthop.2021 sep;45(9):2307-2312.Doi: 10.1007/s00264-021-04972-z.Epub 2021 feb 11.Pmid: 33575857; pmcid: pmc8494697.Objective and methods: the published outcomes of total ankle replacement (tar) implants came from limited institutions creating observational bias.For broader perspective, the authors reviewed the food and drug administration's (fda) manufacturer and user facility device experience (maude) voluntary database to explore complications reported outside published literature associated with 6 different tar manufacturers reported on 648 med watch reports during november 1, 2011 and april 30, 2019.The authors searched the maude database utilizing the fda¿s device classification codes ntg and hsn for the depuy agility tar and 5 competitor constructs to determine the most common reason for adverse event reporting.This complaint will capture the 13 reports associated with the depuy agility tar.The authors do not provide sufficient information to determine the specific med watch report associated with each event.Additionally, there is insufficient information to determine the specifics of each adverse event, the treatments/interventions, and/or the exact devices associated with the events.The following events were reported to the fda as serious injuries or malfunctions.Lot, model and catalog number are not available, but the suspected depuy device possibly associated with reported adverse events: agility ankle: tibial component, tibial insert, talar component and one ankle alignment instrument.Adverse event(s) and provided interventions associated with depuy devices: 1 report of aseptic loosening of an unknown device.6 reports due to alignment/mechanical issues including instability and malposition.1 report due to implant/instrumentation associated with intraoperative alignment instrumentation and possible tibial fracture.1 report associated with impingement with could include soft tissue impingement and/or heterotopic ossification.

Manufacturer Narrative

Product complaint # (b)(4).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.

Manufacturer Narrative

Product complaint # (b)(4).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.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNK ALIGNMENT DEVICE
• Type of Device: UNK ALIGNMENT DEVICE
• 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: 15175701
• MDR Text Key: 297343185
• Report Number: 1818910-2022-15247
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK ALIGNMENT DEVICE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2022
• 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