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 Unspecified Infection (1930); No Code Available (3191)

Event Date 07/26/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The literature article entitled, "mid-term outcome of total hip arthroplasty in patients with progressive pseudorheumatoid dysplasia" written by michel-henri fessy, md, phd, laurent jacquot, md, jean-charles rollier, md, julien chouteau, md, phd.Tarik ait-si-selmi, md, hugo bothorel, meng, and jean-christophe chatelet, md published by the journal of arthroplasty made available online on 26 july 2019.The article's purpose was to report the 10 year survival of a contemporary dm cup (non-depuy) as well as its clinical and radiographic outcomes.It is noted that depuy uncemented corail stem was utilized in all the patients.The femoral head and liner were non-depuy.Table 2 provides patient identifiers of patients who received revisions.This complaint captures those patients with revisions related to the stem.Depuy product: corail stem.Adverse events: patient 11, (b)(6) female revised for deep sepsis, stem size 10.

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.

• 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: 10879239
• MDR Text Key: 217640195
• Report Number: 1818910-2020-25172
• 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: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• 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: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention