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

Catalog Number UNK HIP FEMORAL AUGMENT

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003)

Patient Problem Inadequate Osseointegration (2646)

Event Date 04/19/2005

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, "treatment of periprosthetic femoral shaft nonunion" written by alpesh a.Patel, md, william m.Ricci, md, douglas j.Mcdonald, md, joseph borrelli, md, and john c.Clohisy, md published by the journal of arthroplasty vol.21 no.3 2006 accepted by publisher 19 april 2005 was reviewed.The article's purpose: "to review the current surgical treatment of periprosthetic femoral nonunions and its associated outcomes." data was compiled from 13 patients with periprosthetic femoral shaft nonunions treated between 1995 and 2002.Original implants are not known.Three patients were treated with depuy srom stem and one of these had an associated adverse event.Cross reference of table 1 and narrative description, patient was a (b)(6) male with original diagnosis of oa and received tha (implants unknown) and experienced a type b2 femoral fracture.He was treated with orif in which a depuy srom stem was utilized.His follow up with 24 months duration and he experienced a persistent non-union and unstable srom stem.Narrative descriptions provides further detail that at 24 month follow up patient was "symptomatic" (specific symptoms not indicated), radiographs showed implant loosening, hardware failure and hypertrophic fracture nonunion.The patient was not able to have revision due to "profound medical comorbidities." depuy products utilized: srom stem.Adverse events: stem loosening.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes 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.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 AUGMENT
• Type of Device: HIP FEMORAL AUGMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9430864
• MDR Text Key: 220005806
• Report Number: 1818910-2019-121532
• 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: 11/15/2019

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 AUGMENT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/15/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 01/13/2020
• Supplement Dates FDA Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1