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

Catalog Number UNK HIP FEMORAL STEM

Device Problem Fracture (1260)

Patient Problem Pain (1994)

Event Date 01/01/2016

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.(b)(4).

Event Description

The literature article entitled, "fracture of a spline of the femoral stem in an ingrown modular hip implant" written by david clinton mcnabb, jason m.Jennings, and douglas a.Dennis published by hip international published online 19 july 2016 was reviewed.The article's purpose was to report on one case of (b)(6) female that received a right tha in august 2008 with a pinnacle cup, marathon liner, srom stem and ceramic femoral head all depuy.One year post op she experienced pain in anterior hip and diagnosed with anti-inflammatory medications with diagnosed iliopsoas tendinitis.She became pain free until 3 years post op she had a minor fall and developed pain but radiographs revealed no fracture or implant failure.She again was obtain pain free status over the next few weeks and then on her 7th annual follow up her radiographs revealed a fracture of the anterior spline of the femoral stem but she was pain free.Patient was notified and her athletic activities were limited until a follow up 3 months later with a follow up radiograph which revealed no component loosening, no osteolysis and no change in the anterior spline fracture.Patient resumed activities and continues her active life style without pain or limitation.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes heen able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not bsynthes 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.H10 additional narrative: product complaint (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.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: 9452560
• MDR Text Key: 187857010
• Report Number: 1818910-2019-122438
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1