MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 12/14 ARTICUL 40MM M SPEC+1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number 1365-05-000

Device Problems Naturally Worn (2988); No Apparent Adverse Event (3189)

Patient Problems Fall (1848); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Necrosis (1971); Pain (1994); Tissue Damage (2104); Distress (2329); Discomfort (2330); Injury (2348); Deformity/ Disfigurement (2360); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 03/21/2019

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

The patient was revised due to metallosis.The head and liner were exchanged (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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

(b)(4) used to capture blood heavy metal increased.

Event Description

Litigation alleges friction and wear, between the co-cr metal head and liner caused large amount of toxic metal ions and particles released into the blood, tissues and bone surrounding the implant resulting to pain, discomfort, inflammation, loss of mobility, fall, disfigurement and emotional distress.

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: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H6 patient code: no code available (1932) used to capture the patient code medical device removal.H6 patient code: inflammation (1932) used to capture the patient code bursitis.

Event Description

Pfs alleges metallosis, immobility, hip pain preventing normal activities including standing and walking, increased likelihood of another future hip revision and bursitis.After review of medical records, the patient was revised to address metallosis with pain.The patient was noted to have elevated metal ions and mri findings consistent with an adverse local tissue reaction.Intraoperative findings include bone loss along the calcar but with a well fixed stem, a large amount of necrotic, pseudotumor type tissue on the acetabular area and atrophy of the gluteus medius.The cup and stem were retained.Head and liner were revised.Doi: (b)(6) 2007 - dor: (b)(6) 2019 (left hip).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 12/14 ARTICUL 40MM M SPEC+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: 8505335
• MDR Text Key: 141639903
• Report Number: 1818910-2019-90458
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295032960
• UDI-Public: 10603295032960
• Combination Product (y/n): N
• PMA/PMN Number: K060031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/30/2020

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: 05/31/2012
• Device Model Number: 1365-05-000
• Device Catalogue Number: 136505000
• Device Lot Number: 2388360
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/21/2019
• Initial Date FDA Received: 04/11/2019
• Supplement Dates Manufacturer Received: 04/26/2019; 05/07/2019; 01/30/2020; 02/17/2020
• Supplement Dates FDA Received: 04/30/2019; 05/14/2019; 02/14/2020; 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 104