MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 12/14 ARTICUL 40MM M SPEC+5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Catalog Number 136506000

Device Problem Naturally Worn (2988)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Discomfort (2330); Injury (2348); Deformity/ Disfigurement (2360); Reaction (2414); Test Result (2695); No Code Available (3191)

Event Date 08/24/2018

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.(b)(4).Attorney.

Event Description

Litigation alleged 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 associated with metallosis, pain, discomfort, disfigurement, loss of range of motion, loss of mobility, soreness, negatively affecting the ability to perform activities of daily living, and emotional distress.

Manufacturer Narrative

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, a follow-up medwatch will be filed as appropriate. .

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.Udi: (b)(4).

• Brand Name: 12/14 ARTICUL 40MM M SPEC+5
• 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: 8028921
• MDR Text Key: 125903959
• Report Number: 1818910-2018-74200
• 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: other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/12/2018

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 Expiration Date: 08/31/2014
• Device Catalogue Number: 136506000
• Device Lot Number: 2990864
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/12/2018
• Initial Date FDA Received: 11/01/2018
• Supplement Dates Manufacturer Received: 11/16/2018; 03/12/2019
• Supplement Dates FDA Received: 11/16/2018; 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR