MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICULEZE M HEAD 36MM -2; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number 1365-50-000

Device Problems Corroded (1131); Degraded (1153); Naturally Worn (2988)

Patient Problems Ossification (1428); Pain (1994); Synovitis (2094); Test Result (2695); No Code Available (3191)

Event Date 10/24/2019

Event Type  Injury  

Manufacturer Narrative

(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

Clinical notification received for revision due to metal bearing surface failure.Date of implant: (b)(6) 2007; date of revision: (b)(6) 2019; (right hip).Head and liner revised.

Event Description

Additional information received stating that patient received a head and liner exchange due to pain and blood cobalt levels of 12.9 mcg/l.Upon entering the hip, the surgeon encountered and debrided a grey-colored, thickened, and inflamed periarticular capsule and synovitis.The acetabulum has some excessive bone growth that was removed.The surgeon noted these findings were "consistent with her metal bearing".The cup was well-fixed and retained.The explanted femoral head had evidence of minor corrosion at the trunnion.There were no reported product problems with the explanted liner.The femoral stem was well-fixed, intact, and retained.The patient was revised with a depuy polyethylene liner and ceramic femoral head.The procedure was completed without complications.

Manufacturer Narrative

Product complaint # (b)(4).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.Added: b5, b7 and h6 for patient code.Corrected: h6 (device code).H6 patient code: no code available (3191) used to capture the device revision or replacement.Codes medical device removal and surgical intervention were being retracted to replace code device revision or replacement.

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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ARTICULEZE M HEAD 36MM -2
• 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: 9721653
• MDR Text Key: 188356662
• Report Number: 1818910-2020-05152
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033899
• UDI-Public: 10603295033899
• Combination Product (y/n): N
• PMA/PMN Number: K980513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/19/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 1365-50-000
• Device Catalogue Number: 136550000
• Device Lot Number: 2387969
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/03/2020
• Initial Date FDA Received: 02/18/2020
• Supplement Dates Manufacturer Received: 02/19/2020; 03/30/2020
• Supplement Dates FDA Received: 03/16/2020; 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CORAIL2 NON COL HO SIZE 11(L20311/2363877); PINNACLE SECTOR II CUP 54MM(121722054/B1AGV1000)
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 84