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

Catalog Number UNK HIP FEMORAL STEM

Device Problem Migration (4003)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/09/2017

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.

Event Description

The literature article entitled, "risk of subsidence and peri-prosthetic fractures using collared hydroxyapatite-coated stem for hip arthroplasty in the elderly" written by farhan syed, amr hussein, krishnaiah katam, paul saunders, stepohen k young and mohammad faisal published by hip international accepted by publisher 9 december 2017.The article's purpose was to determine if addition of collar to an uncemented stem makes any significant difference to the risk of subsidence and peri-prosthetic fracture.Data was compiled from 176 patients in the study.All patients received corail stems.Depuy product: corail stem.Adverse events: subsidence progressively tracked for 4 years and subsided a total of 9 mm due to a missed calcar crack.Intraoperative fracture (treated with cabling).

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: 10928408
• MDR Text Key: 218976484
• Report Number: 1818910-2020-25820
• 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: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• 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: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention