MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL STEM TRI-LOCK

Catalog Number UNK HIP STEM TRI-LOCK

Device Problem Malposition of Device (2616)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 09/29/2017

Event Type  malfunction  

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.

Event Description

The literature article, "stem anteversion mismatch to the anatomical anteversion causes loss of periprosthetic bone density after tha" written by shinya hayashi, shingo hashimoto, tomoyuki matsumoto, koji takayama, kotaro nishida, kazunari ishida and ryosuke kuroda published by journal of orthopaedic surgery accepted by publisher on 29 september 2017 was reviewed.The article's purpose was to study the correlations between periprosthetic bone mineral density (bmd) and changing of stem anteversion in patients who underwent tha with a short tapered-wedge stem.Data was compiled from 44 patients who received depuy tri lock bps stem between january 2013 and november 2013 with clinical evaluation performed 24 months postoperatively.The article reports on stem version error and found correlation between anteversion error to gruen zones with bmd loss.The findings indicate that excessive anteversion error causes stem point contact with the femoral bone in the distal portion, leading to proximal periprosthetic bmd loss.Depuy product: trilock stem.Adverse event: bone mineral density loss associated with mispositioned stem (no treatment provided).

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: UNK HIP FEMORAL STEM TRI-LOCK
• Type of Device: FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10858083
• MDR Text Key: 219563458
• Report Number: 1818910-2020-24894
• 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
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP STEM TRI-LOCK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1