MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICULEZE M HEAD 36MM +5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Catalog Number 136552000

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988); Insufficient Information (3190); Noise, Audible (3273)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); No Information (3190); No Code Available (3191)

Event Date 09/17/2012

Event Type  Injury  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.Depuy synthes has been informed that the catalog number and lot number is not available.

Event Description

Litigation alleges patient was revised to address pain, discomfort, popping and clicking, metallosis and metal stained tissue.

Manufacturer Narrative

Litigation alleges patient was revised to address pain, discomfort, popping and clicking, metallosis and metal stained tissue.Examination of the reported devices was not possible as they were not returned.A search of the complaints databases and/or a review of device history records were not possible as the required product/lot code combinations were not provided.The investigation can draw no conclusion regarding the reported event with the information available.Based on the inability to determine root cause, the need for corrective action has not been indicated.Depuy 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.

Manufacturer Narrative

Depuy still considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Event Description

Update 2/10/2017 - pfs and medical records received.After review of the medical records for mdr reportability, alleges sharp pain and discomfort in right hip to knee, grabbing, trouble walking (requires cane), and difficulty doing everyday things.Constantly feels like could fall and falls often, instability.Revising surgeon indicated patient had recurrent instability with right hip having dislocated three times.Stated in operative note that there was metal staining of reactive tissue with fluid.Opening the capsule, indicated that there was a "marked synovitic reaction with metallosis or metal staining".Indicated that femoral and acetabular components were in excellent position with the correct amount of anteversion.No implant loosening identified.No prod/lot information available.Dislocation and instability added to complaint.There is no new additional information that would affect the existing mdr decision.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.No device associated with this report was received for examination.The adverse symptoms alleged and product code reported is associated with the depuy metal on metal articulation.A complaint database search and/or device manufacturing (dhr) reviews will not be performed.Per wi-3430 it has been determined that should related reports be identified a dhr review is not required.Per nr-0134037 a medical record review is not required for this complaint record.Investigational inputs were requested as indicated per internal procedures for this failure mode.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Per internal procedures, the event information and any investigational inputs received as part of required follow up were reviewed.For this investigation, no immediate action was required as no alleged deficiency with the device(s) was identified.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

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.H10 additional narrative: added: h6(device code).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 +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: 6124323
• MDR Text Key: 60787379
• Report Number: 1818910-2016-32093
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• PMA/PMN Number: K980513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/10/2017

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: 04/01/2008
• Device Catalogue Number: 136552000
• Device Lot Number: 1098933
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/02/2016
• Initial Date FDA Received: 11/23/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 08/13/2019; 11/11/2019; 02/13/2020
• Supplement Dates FDA Received: 01/09/2017; 03/05/2017; 08/19/2019; 11/18/2019; 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 86