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

Catalog Number UNK HIP FEMORAL STEM

Device Problems Use of Device Problem (1670); Loss of Osseointegration (2408); Malposition of Device (2616)

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 10/19/2019

Event Type  Injury  

Manufacturer Narrative

(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, "the effect of size for a hydroxyapatite-coated cementless implant on component revision in total hip arthroplasty: an analysis of 41,265 stems" written by wayne t.Hoskins, phd, roger j.Bingham, fracs, michelle lorimer, and richard n.De steiger, phd, fracs (orth) published by the journal of arthroplasty accepted by publisher 30 october 2019 was reviewed.The article's purpose was to investigate whether there was a difference in revision rate for smaller stems with focus on depuy corail stems.Data was compiled from 41,265 primary thas from the australian orthopaedic association national joint replacement registry.The article notes that the smaller corail stems have 4 times the rate of revision compared with the larger femoral sizes.It is assumed that the corail stems were utilized with depuy femoral heads, cups and liners.Depuy products identified: corail stem.Adverse events: revisions for loosening, dislocation, infection, femur fracture and malposition.No further information provided regarding reasons for revision.

Manufacturer Narrative

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.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.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: 9636094
• MDR Text Key: 188195542
• Report Number: 1818910-2020-03137
• 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,health professional,l
• Type of Report: Initial,Followup
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention