MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ARTICULEZE M 28MM 5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Catalog Number 136512500

Device Problem Material Disintegration (1177)

Patient Problems Tissue Damage (2104); Test Result (2695); No Code Available (3191)

Event Date 11/15/2016

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

Ppf and medical records received.Ppf alleges pseudotumor, constrained liner, metal wear, metallosis and elevated metal ions.After review of medical records, no revision notes provided.

Manufacturer Narrative

Product complaint # (b)(4).No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.

• Brand Name: ARTICULEZE M 28MM 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: 8270821
• MDR Text Key: 133860543
• Report Number: 1818910-2019-82005
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033097
• UDI-Public: 10603295033097
• Combination Product (y/n): N
• PMA/PMN Number: K843909
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2006
• Device Catalogue Number: 136512500
• Device Lot Number: XVA30
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR