MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN ANKLE TIBIAL

Catalog Number UNK ANKLE TIBIAL

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)

Patient Problems Cyst(s) (1800); Non-union Bone Fracture (2369); Inadequate Osseointegration (2646); Insufficient Information (4580)

Event Date 01/01/2021

Event Type  Injury  

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.

Event Description

Article entitled "the impact of coronal plane deformity on ankle arthrodesis and arthroplasty¿ written by michael d.Johnson, md, jane b.Shofer, ms, sigvard t.Hansen jr., md, william r.Ledoux, phd, and bruce j.Sangeorzan, md published in american orthopaedic foot and ankle surgery in 2021 was reviewed.The purpose of this article was to investigate outcomes in patients with complex coronal deformity who received arthroplasty vs arthrodesis.75 arthroplasty patients are involved in the study which was divided into two groups.29 patients were included within the tilted coronal malalignment and 12 were implanted with a depuy agility ankle.46 patients were included within the non-tilted corneal malalignment group and 24 were implanted with a depuy agility ankle.Adverse events: tilted group: 5 reoperations involved depuy agility ankle (syndesmotic nonunion, tibia failure, recurrent valgus, osteolysis with cyst, and osteolysis with loosening).Non-tilted group: 3 reoperations involved depuy agility ankle (midfoot fusion, component revision for talar collapse, and syndesmosis nonunion).

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: UNKNOWN ANKLE TIBIAL
• Type of Device: ANKLE TIBIAL
• 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: 15175966
• MDR Text Key: 297347436
• Report Number: 1818910-2022-15254
• Device Sequence Number: 1
• Product Code: HSN
• 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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ANKLE TIBIAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2022
• 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