MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 ARTICULEZE M HEAD 36MM +1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Catalog Number 136551000

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

Patient Problems Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Discomfort (2330); Injury (2348); Deformity/ Disfigurement (2360); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 04/25/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Concomitant med products: articuleze m head 36mm +1.5 hip femoral head; pinnacle mtl ins neut36idx52od hip acetabular liner; unknown hip acetabular cup; unknown hip femoral stem initial reporter occupation: non-healthcare professional ¿ attorney.Patient codes: (b)(4) no code available is to address the reported ¿surgical intervention¿.

Event Description

Complaint description: der stated alval.Additional information received: suspicion of alval update ad 13 sep 2018 (b)(4) is reopened under (b)(4) due to receipt of pinnacle metal on metal litigation received.In addition to what was previously reported, litigation alleges injury, discomfort, pain, stiffness, loss of motion, metallosis, necrosis, soft tissue damage, muscle damage, emotional distress, loss of mobility, loss of range of motion, mental anguish, and disfigurement.The patient harms, law firm, lawyer have been added.The manufacturing date has been updated.Doi: (b)(6) 2006; dor: (b)(6) 2017; right hip.

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).

Event Description

Ppf alleges elevated metal ions.

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).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 : 2023713.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.

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 +1.5
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY FRANCE SAS 3003895575; 7 allée irène joliot curie; bp 256; saint priest cedex IN 69801 ; FR 69801
• MDR Report Key: 7955518
• MDR Text Key: 123366458
• Report Number: 1818910-2018-72081
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033912
• UDI-Public: 10603295033912
• 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,Followup
• Report Date: 09/13/2018

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: 136551000
• Device Lot Number: 2023713
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/13/2018
• Initial Date FDA Received: 10/11/2018
• Supplement Dates Manufacturer Received: 03/12/2019; 04/17/2019; 11/25/2019
• Supplement Dates FDA Received: 04/01/2019; 05/08/2019; 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 92