MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ARTICULEZE M HEAD 36MM +8.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Catalog Number 136553000

Device Problems Corroded (1131); Material Disintegration (1177); Insufficient Information (3190)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Distress (2329); Discomfort (2330); Injury (2348); Deformity/ Disfigurement (2360); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); Not Applicable (3189)

Event Date 05/07/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter is an attorney.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pinnacle litigation received.Litigation alleges injury, pain, discomfort, loss of mobility, loss of range of motion, disfigurement, emotional distress, difficulty ambulating, mental anguish, metallosis which cause a large amount of toxic cobalt and chromium metal ions to be released in hip capsule, tissues, blood stream, and organs.Doi: (b)(6) 2006; dor: (b)(6) 2014; right hip.

Manufacturer 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, 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

(b)(4).

Event Description

Update ad 11 sep 2018.Pc was re-opened due to the receipt of ppf and sticker sheets.In addition to what were previously alleged, ppf alleges metal wear.Added revision hospital, surgeon, dob, product details and expiration date.

Manufacturer Narrative

(b)(4).

Event Description

In addition to what were previously alleged, pfs has no new allegation.After review of medical records, patient was revised to address failed acetabular component, there was evidence of corrosion between cobalt-chromium head from the stem.The cup did not show any evidence of loosening.All debris then removed.

• Brand Name: ARTICULEZE M HEAD 36MM +8.5
• 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
• Manufacturer (Section G): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds IN LS11 8DT; UK LS11 8DT
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avemue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 7884865
• MDR Text Key: 120534455
• Report Number: 1818910-2018-69614
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/23/2018

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: 06/30/2011
• Device Catalogue Number: 136553000
• Device Lot Number: 2186216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/23/2018
• Initial Date FDA Received: 09/18/2018
• Supplement Dates Manufacturer Received: 09/25/2018; 02/07/2019; 02/28/2019
• Supplement Dates FDA Received: 09/26/2018; 02/19/2019; 03/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR