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

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); No Code Available (3191)

Event Date 04/14/2020

Event Type  malfunction  

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, "greater increase in femoral offset with use of collum femoris-preserving stem than tri-lock stem in primary total hip arthroplasty" written by mengxuan yao, yuchuan wang, congcong wei, yongtai han and huijie li published by journal of international medical research accepted by publisher on 14 april 2020 was reviewed.The article's purpose was to compare clinical outcomes and performance of the collum femoris-preserving stem verse the tri-lock stem.Data was compiled from 65 and 57 patients respectively who received these stems from january 2016 to march 2017.The article reports the depuy tri lock stem was used with a depuy titanium acetabular cup so it is assumed the femoral head (unknown material) and liner (unknown material) are also depuy.Figures 1 and 2 provide radiographic imaging for illustrative purposes.No adverse events noted in descriptive captions.Depuy products: tri-lock stem, femoral head, liner, titanium cup.Adverse event(s): dislocation (treatment not stated).Leg length discrepancy (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: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10879660
• MDR Text Key: 244224786
• Report Number: 1818910-2020-25181
• 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: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/12/2020
• Initial Date FDA Received: 11/20/2020
• Supplement Dates Manufacturer Received: 12/18/2020
• Supplement Dates FDA Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1