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

Catalog Number 136550000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Tissue Damage (2104); Discomfort (2330); Injury (2348); Deformity/ Disfigurement (2360); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)

Event Date 07/09/2018

Event Type  Injury  

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.Reporter is a non-healthcare professional.(b)(4).

Event Description

Patient was revised due to loose acetabular cup related to poor bone growth.Cup was loose at bone to implant interface.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, soreness, negatively affecting the ability to perform activities of daily living, and emotional distress.Doi: unknown; dor: (b)(6) 2018; unknown hip.

Manufacturer Narrative

(b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.On 11/15/2018 additional information and new patient harms received.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

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).

• 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 46582 0988
• MDR Report Key: 8006385
• MDR Text Key: 125038287
• Report Number: 1818910-2018-73544
• 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: 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: 136550000
• Device Lot Number: 2980851
• Initial Date Manufacturer Received: 10/12/2018
• Initial Date FDA Received: 10/25/2018
• Supplement Dates Manufacturer Received: 11/15/2018; 03/12/2019
• Supplement Dates FDA Received: 11/15/2018; 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR