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

Catalog Number UNK HIP FEMORAL STEM

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

Patient Problems Bone Fracture(s) (1870); Injury (2348); No Code Available (3191)

Event Date 11/16/2016

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).(b)(4).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

The literature article entitled, "long-term results of cementless total hip arthroplasty with subtrochanteric shortening osteotomy in crowe type iv developmental dysplasia" written by duan wang, md, ling-li li, md, hao-yang wang, md, fu-xing pei, md, and zong-ke zhou, md, phd published by the journal of arthroplasty 32 (2017) 1211e1219 http://dx.Doi.Org/10.1016/j.Arth.2016.11.005 on 15 november 2016 was reviewed for mdr reportability.The article's purpose: "the purpose of this study was to evaluate 10-year functional and radiographic results of cementless and modular thas combined with transverse subtrochanteric shortening osteotomy in a group of consecutive hips with crowe type iv-hartofilakidis type iii ddh." data consisted of 76 hips in 62 patients receiving tha implants between september 2002 and december 2010 with average follow up of 10 years.Products are depuy pinnacle cups fixed with dome screws in all hips, depuy srom cementless stems, and coc bearings in 60 hips and mop in 16 hips.It is reasonable to conclude the femoral head was also a depuy product.Noted adverse events: dislocations (treated with closed reduction and bed confinement for 3 weeks), transient nerve palsy (treated with medication and recovered within 8 months without deficit), non union presumably of femur due to osteotomy procedure, intraoperative fractures of femur (all treated with cerclage wiring), revision surgeries for isolated loosening of acetabular component case and femoral stem loosening case.The article does not provide adequate information to provide accurate quantities as patients may experience more than 1 adverse event.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision depuy synthes 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.Product complaint # (b)(4).Investigation summary : no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9181996
• MDR Text Key: 173007523
• Report Number: 1818910-2019-109474
• 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: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention