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

Catalog Number UNK HIP FEMORAL STEM

Device Problem Loss of Osseointegration (2408)

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Pain (1994); Weakness (2145); Inadequate Osseointegration (2646); No Code Available (3191)

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

A literature article entitled ¿clinical outcomes and midterm survivorship of an uncemented primary total hip arthroplasty system¿, written by harman chaudhry, md, et al, published in the journal of arthroplasty on 23 january 2020, https://doi.Org/10.1016/j.Arth.2020.01.063, was reviewed.The purpose of this article was to report the functional outcomes, revision data, and survivorship for this total hip system based on data from a prospective database.Depuy products used: pinnacle acetabular shell; summit cementless femoral stem.A total of 57 revisions took place for adverse events as follows: loosening of the femoral component.Periprosthetic fracture (all involved the femoral side only).Recurrent instability.Infection (included incision and drainage with head and liner exchange in 24 cases, of which 8 required eventual component removal as a first-stage revision; immediate definitive 2-stage revision with removal of all components and placement of antibiotic spacer was used in 10 cases).Abductor deficiency.Squeaking.Pain.The article does report at least screw was used in the acetabular cup, however does not exact quantities.

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.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.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 STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9945277
• MDR Text Key: 189850165
• Report Number: 1818910-2020-10607
• Device Sequence Number: 1
• Product Code: KWY
• 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: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/03/2020
• Initial Date FDA Received: 04/09/2020
• Supplement Dates Manufacturer Received: 04/21/2020
• Supplement Dates FDA Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention