MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICULEZE M HEAD 36MM +8.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Catalog Number 136553000

Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Muscular Rigidity (1968); Pain (1994); Tissue Damage (2104); Weakness (2145); Anxiety (2328); Discomfort (2330); Injury (2348); Hypoesthesia (2352); Deformity/ Disfigurement (2360); Joint Disorder (2373); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 06/04/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Initial reporter occupation: lawyer.(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

Pinnacle mom litigation records received.Litigation alleges pain, discomfort, emotional distress, disfigurement and injuries.Doi: (b)(6) 2010; dor: (b)(6) 2018; right 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.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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.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.

Event Description

Ppf alleges metal wear, metallosis and elevated metal ions, while pfs alleges numbness, stiffness, instability, weakness, limited rom, soft tissue destruction and anxiety.After review of medical records, the patient was revised due to failed right tha, with metallosis and soft tissue destruction.Operative notes reported that upon entering he intra-articular spaces, metallosis debris was expelled and there was evident of some metal staining of the soft tissue.There was some trunnion corrosion and debris, but the trunnion looked intact.The femur was 5-10 degrees anteversion.Tte liner has some old staining behind it, including some metallosis and corrosion.

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. no code available (3191) is used to capture (medical device removal and blood heavy metal increase).

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.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.

• Brand Name: ARTICULEZE M HEAD 36MM +8.5
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8597212
• MDR Text Key: 144616588
• Report Number: 1818910-2019-93074
• Device Sequence Number: 1
• Product Code: JDI
• 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: 01/07/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Catalogue Number: 136553000
• Device Lot Number: 3085140
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/19/2019
• Initial Date FDA Received: 05/09/2019
• Supplement Dates Manufacturer Received: 05/30/2019; 01/07/2020; 01/24/2020
• Supplement Dates FDA Received: 05/31/2019; 01/08/2020; 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 66