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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Pocket Erosion (2013); No Code Available (3191)

Event Date 07/14/2014

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

After review of medical records patient was revised to address failed total hip arthroplasty on the left secondary to metal on metal reactive bone and soft tissue disease.There was also pain reported.Revision notes reported that there was extensive metallosis reaction of the soft tissue.The pseudotumor was visible within the trochanter region at the level of the band and extended proximally and distally.The entire trochanteric region had been destroyed by the pseudotumor and lost the attachment of the adductors and bone erosion of the trochanter.There was also significant amount of fluid reaction involved which was grey and cloudy.Cup and screw were also removed.Doi: (b)(6) 2007; dor: (b)(6) 2014 (left hip).

Manufacturer Narrative

This is a duplicate report of 1818910-2017-11795.1818910-2020-08631 is being retracted as it is a report duplication.1818910-2017-11795 will be kept for investigation purposes.

• 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: 9854330
• MDR Text Key: 188844001
• Report Number: 1818910-2020-08631
• 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: 02/28/2020

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: 10/31/2012
• Device Model Number: 1365-51-000
• Device Catalogue Number: 136551000
• Device Lot Number: 2481707
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/28/2020
• Initial Date FDA Received: 03/19/2020
• Supplement Dates Manufacturer Received: 04/22/2020
• Supplement Dates FDA Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR