MAUDE Adverse Event Report: DEPUY IRELAND 9616671 DLT TS CER HD 12/14 36MM +8.5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Catalog Number 136536730

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problems Cardiac Arrest (1762); Infarction, Cerebral (1771); Unspecified Infection (1930); Joint Dislocation (2374); Test Result (2695); No Code Available (3191)

Event Type  Injury  

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.Occupation is a non-healthcare professional.(b)(4).

Event Description

Litigation alleges stroke, heart attack, component fracture, dislocation, infection, loosening of stem and elevated metal ions.Doi: (b)(6) 2011 (head, liner & stem); doi: (b)(6) 2009 (cup, screw); dor: (b)(6) 2012 (right hip).

Manufacturer Narrative

This is a duplicate report of 1818910-2013-22514.1818910-2019-90651 is being retracted as it is a report duplication.1818910-2013-22514 will be kept for investigation purposes.Product complaint # (b)(4).

• Brand Name: DLT TS CER HD 12/14 36MM +8.5
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8514068
• MDR Text Key: 141926700
• Report Number: 1818910-2019-90651
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033677
• UDI-Public: 10603295033677
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071830
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/25/2019

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: 06/30/2015
• Device Catalogue Number: 136536730
• Device Lot Number: 3154447
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/25/2019
• Initial Date FDA Received: 04/15/2019
• Supplement Dates Manufacturer Received: 05/14/2019
• Supplement Dates FDA Received: 05/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2010
• 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