MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ARTICULEZE M HEAD 36MM +1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Catalog Number 136551000

Device Problems Corroded (1131); Naturally Worn (2988)

Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Scar Tissue (2060); Swelling (2091); Tissue Damage (2104); Discomfort (2330); Osteolysis (2377); No Code Available (3191)

Event Date 04/27/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.(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

After review of medical records, it was stated that the patient was revised to address pain, osteolysis, articular bearing wear, metallosis, discomfort, stiffness and swelling.Operative notes indicate that there was an abundant amount of scar tissues.There was about 30 ml of milky fluid retrieved which the surgeon thought was consistent of a metal on metal reaction.There was also an abundant amount of synovitis resected from within the left hip socket and from the rim of the cup.The surgeon sent some samples to the laboratory and the result was consistent with chronic inflammation.There was minimal corrosion on the trunnion.(left hip).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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: null.Device history batch: null.Device history review: null.

• 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. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8527393
• MDR Text Key: 142359206
• Report Number: 1818910-2019-91014
• 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: other
• Type of Report: Initial,Followup
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 136551000
• Device Lot Number: 1955540
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR