MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICULEZE M HEAD 36MM +1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number 1365-51-000

Device Problem Noise, Audible (3273)

Patient Problems Arrhythmia (1721); Headache (1880); Pyrosis/Heartburn (1883); Itching Sensation (1943); Pain (1994); Loss of Range of Motion (2032); Rash (2033); Tinnitus (2103); Discomfort (2330); Ambulation Difficulties (2544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported by the patient that that " i had my right hip & knee replaced (b)(6) 2006 and my left hip replaced (b)(6) 2007.I began having left hip problems in 2016.I went to the original operating doctor to have it checked.At that time he did not find a solution for my discomfort.He did, however take a cobalt test at that time.It came back at 7.2.This year he took another cobalt test on (b)(6) 2020 and the results were 16.4.After review of medical records, it was determined that the patient experienced limited mobility accompanied by sensation that hip ball has come out of the socket and went back in.In 2016 patient felt/heard an audible pop.Revision notes stated that a scar tissue was removed.Head and liner were revised.Doi: (b)(6) 2007 - dor: (b)(6) 2020 (left 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.Device history lot : a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.

• Brand Name: ARTICULEZE M HEAD 36MM +1.5
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11474745
• MDR Text Key: 239490804
• Report Number: 1818910-2021-05001
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033912
• UDI-Public: 10603295033912
• Combination Product (y/n): N
• PMA/PMN Number: K980513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 03/02/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2012
• Device Model Number: 1365-51-000
• Device Catalogue Number: 136551000
• Device Lot Number: 2360685
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/02/2021
• Initial Date FDA Received: 03/12/2021
• Supplement Dates Manufacturer Received: 10/28/2021
• Supplement Dates FDA Received: 10/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +1.5; PINNACLE 300 ACET CUP 52MM; PINNACLE MTL INS NEUT36IDX52OD; SUMMIT POR TAPER SZ5 HI OFF; APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +1.5; PINNACLE 300 ACET CUP 52MM; PINNACLE MTL INS NEUT36IDX52OD; SUMMIT POR TAPER SZ5 HI OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR