MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 12/14 ARTICUL 44MM M SPEC+5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Catalog Number 136562000

Device Problems Naturally Worn (2988); Insufficient Information (3190)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Discomfort (2330); Injury (2348); Deformity/ Disfigurement (2360); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

Event Date 05/02/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pinnacle litigation record received.Litigation alleges friction and wear between the metal head and liner caused the release of toxic metal ions and particles into the patient's body resulting to injury, pain, discomfort, soreness, disfigurement, mental anguish, suffering, emotional distress and inability to perform normal daily activities.

Manufacturer Narrative

Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.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. .

Manufacturer Narrative

(b)(4).Investigation summary
=
> no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.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.

Event Description

In addition to what previously alleged, ppf alleged metallosis.

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.Udi: (b)(4).Product complaint # (b)(4).

• Brand Name: 12/14 ARTICUL 44MM M SPEC+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: 7978863
• MDR Text Key: 124135303
• Report Number: 1818910-2018-72887
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K060031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/26/2018

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 Catalogue Number: 136562000
• Device Lot Number: 2462890
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/26/2018
• Initial Date FDA Received: 10/18/2018
• Supplement Dates Manufacturer Received: 11/15/2018; 03/07/2019; 06/20/2019
• Supplement Dates FDA Received: 11/15/2018; 03/25/2019; 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR