MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL AUGMENT

Catalog Number UNK HIP FEMORAL AUGMENT

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

Patient Problems Pulmonary Embolism (1498); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Joint Disorder (2373); Joint Dislocation (2374); Osteolysis (2377); Test Result (2695); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Product complaint #
=
> (b)(4).Additional narrative: patient code: no code available ((b)(4)) used to capture surgical intervention and bursitis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.-(b)(4).

Event Description

On (b)(6) 2019 literature article entitled: ¿midterm prospective comparative analysis of 2 hard-on-hard bearing total hip arthroplasty designs¿ by j.Ryan martin, md, jason m.Jennings, md, tyler s.Watters, md, dan l.Levy, bs, todd m.Miner, md, douglas a.Dennis, md.Published by the journal of arthroplasty 33 (2018) was reviewed for mdr reportability.The study¿s objective was to prospectively compare the midterm outcomes of a metal-on-metal and a ceramic-on-ceramic total hip arthroplasty cohort, specifically the revision, reoperation, and complication rates.40 consecutive patients were enrolled for the mom cohort by one surgeon, and 42 consecutive patients were enrolled for the coc by the other surgeon.The models of prostheses used include depuy pinnacle acetabular components with depuy metal ultamet liner, depuy metal femoral head, depuy summit femoral stem.As well as depuy ceramax ceramic liner, depuy biolox delta ceramic femoral head, depuy srom femoral stem and srom sleeve.The study identified the following to be adverse outcomes, patient quantity is stated if provided: 1.) 11 adverse local tissue reaction 2.) 9 pseudotumor 3.) 2 osteolysis 4.) 1 acetabular component loosening 5.) 2 superficial infection 6.) 3 deep infection 7.) 4 trochanteric bursitis 8.) 2 dislocation 9.) 1 pulmonary embolism 10.) instability 11.) elevated blood metal ions 12.) revision / surgical intervention.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.H10 additional narrative: product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL AUGMENT
• Type of Device: HIP FEMORAL AUGMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9164894
• MDR Text Key: 169083337
• Report Number: 1818910-2019-107948
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL AUGMENT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention