MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 12/14 ARTICUL 40MM M SPEC+5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Catalog Number 136506000

Device Problem Material Disintegration (1177)

Patient Problems Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Distress (2329); Discomfort (2330); Deformity/ Disfigurement (2360); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

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.Concomitant med products: unknown hip femoral head; unknown hip acetabular liner; unknown hip acetabular cup; unknown hip femoral stem.(b)(6).

Event Description

Pinnacle litigation received.Litigation alleges friction and wear between the cobalt-chromium metal head and cobalt-chromium metal insert caused large amounts of toxic metal ions and particles to be released into the patient's blood, tissue, and bone surrounding the implant.As a result, the patient experienced injuries, pain, discomfort, inflammation, loss of mobility, loss of range of motion, mental anguish, emotional distress, and disfigurement.Doi: (b)(6) 2008; dor: none reported; right hip.

Manufacturer Narrative

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, post market surveillance, 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.

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 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. udi: (b)(4).

• Brand Name: 12/14 ARTICUL 40MM M SPEC+5
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7897327
• MDR Text Key: 120975421
• Report Number: 1818910-2018-69999
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K060031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2013
• Device Catalogue Number: 136506000
• Device Lot Number: 2666558
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/27/2018
• Initial Date FDA Received: 09/21/2018
• Supplement Dates Manufacturer Received: 09/27/2018; 03/04/2019
• Supplement Dates FDA Received: 09/28/2018; 03/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other