MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 UNKNOWN HIP FEMORAL AUGMENT

Catalog Number UNK HIP FEMORAL AUGMENT

Device Problems Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pain (1994); No Code Available (3191)

Event Date 06/18/2010

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, "failed metal-on-metal hip arthroplasties a spectrum of clinical presentations and operative findings" by james a.Browne, md, dustin bechtold, md, daniel j.Berry, md, arlen d.Hanssen, md, and david g.Lewallen md published by clinical orthopaedics related research on 18 june 2010; doi: 10.1007/s11999-010-1419-0 was reviewed for mdv reportability.The article's purpose: "we therefore describe the (1) clinical presentations; (2) reasons for failure; (3) operative findings; and (4) histologic findings in patients with failed metal-on-metal hip arthroplasties.The purpose of this report is to focus on this critical and controversial clinical issue and detail our observational findings in patients who appear to have failed from adverse reactions to metal debris.The data is pulled from 37 patients who had a revision of a failed metal-on-metal articulation between september 1, 2006 and august 31, 2009.Depuy products have been identified along with patient identifiers in table 1 (revision without armd) and table 2 (revision with confirmed armd) for a total of 11 patients for revision without armd (case #: 5, 12, 13, 14, 16, 18, 19, 22, 23, 24, and 25) and a total of 4 patients for revision with confirmed armd (case #2, 4, 7, 10).The cases are individually captured on linked complaints.Case #14 of table 1: (b)(6) yo male, received revision for infection 22 months post initial tha and received resection followed by two stage revision of depuy asr.

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: this hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.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 INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds IN LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 9064252
• MDR Text Key: 160322377
• Report Number: 1818910-2019-104553
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL AUGMENT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR