MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ARTICULEZE M HEAD 36MM +5; HIP FEMORAL HEAD

Catalog Number 136552000

Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Foreign Body Reaction (1868); Memory Loss/Impairment (1958); Neuropathy (1983); Pain (1994); Vertigo (2134); Injury (2348); Depression (2361); Osteolysis (2377); Test Result (2695); No Code Available (3191)

Event Date 12/21/2018

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.510k: this report is for an unknown device/unknown lot.Part and lot number are unknown; udi number is unknown.(b)(4).Device was used for treatment, not diagnosis.

Event Description

It was reported that litigation alleges abnormally high levels of both cobalt and chromium, injury, pain, suffering, emotional distress, mental anguish, loss of enjoyment of life, and disability.Date of implant is (b)(6) 2006 and date of revision of right hip is (b)(6) 2018.

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 #
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> (b)(4).Investigation summary
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> 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, a follow-up medwatch will be filed as appropriate.

Event Description

Ppf alleged metallosis and metal wear.Pfs alleges metallosis with metal and psychological changes, along with cognitive issues involving memory, focus and attention, depression, lack of energy, severe gastrointestinal issue, neuropathy in feet, liver and kidney disturbances, balance issue and vertigo.After review of medical records, the patient was revised for failed metal on metal right hip replacement (metallosis) with osteolysis formation.Operative notes reported s reported evidence of copious amount of black looking fluid.There was significant osteolysis around the anterior, posterior, and medial of the femoral neck.

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.H10 additional narrative: patient code: no code available (3191) used to capture the patient code surgical intervention and medical device removal.

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.Patient code: no code available ((b)(4)) used to capture the device revision or replacement, emotional distress, gastrointestinal injury and balance disorder.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 report, a follow-up report will be filed as appropriate.

• Brand Name: ARTICULEZE M HEAD 36MM +5
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8336522
• MDR Text Key: 136051225
• Report Number: 1818910-2019-84421
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/04/2020

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 Expiration Date: 08/31/2011
• Device Catalogue Number: 136552000
• Device Lot Number: 2222083
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/25/2019
• Initial Date FDA Received: 02/13/2019
• Supplement Dates Manufacturer Received: 02/26/2019; 02/04/2020; 06/09/2020
• Supplement Dates FDA Received: 02/27/2019; 02/25/2020; 06/10/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR