MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 12/14 ARTICUL 44MM M SPEC+12; HIP FEMORAL HEAD

Catalog Number 136564000

Device Problems Corroded (1131); Insufficient Information (3190)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 09/24/2014

Event Type  Injury  

Event Description

Medwatch report #mw5036483 states: experiencing peripheral neuropathy, memory loss, and varying degrees of constant pain from depuy pinnacle bi-lateral hip implants.Update rec'd (b)(4) 2014 - litigation papers received.In addition to what was previously reported, litigation alleges the patient suffers from damage to his hip joints and his body.A dor has been provided.Products are now being reported to the fda to address revision and litigation.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Manufacturer Narrative

No device associated with this report was received for examination.A worldwide complaint database search found no other reported incidents against the provided product/lot combinations 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.Corrective action was not 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

No device associated with this report was received for examination.A worldwide complaint database search found no other reported incidents against the provided product/lot combinations 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.Corrective action was not 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

Additional narrative: 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.

Event Description

Update 6/3/15-pfs and medical records received.After review of the medical records for mdr reportability, the revision operative note indicated pain, corrosion, and malpositioned cup (wasn't revised).A correct dor was provided.The complaint was updated on: 7/1/2015.

Event Description

Ppf alleges elevated metal ions.

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).

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.Additional 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.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 (b)(4) 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 12/14 ARTICUL 44MM M SPEC+12
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 4371380
• MDR Text Key: 5286869
• Report Number: 1818910-2014-35410
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: PK060031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/08/2014

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: 03/31/2012
• Device Catalogue Number: 136564000
• Device Lot Number: 2359899
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/01/2015
• Initial Date FDA Received: 12/30/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 04/02/2019; 12/09/2019
• Supplement Dates FDA Received: 02/09/2015; 07/02/2015; 07/06/2015; 04/23/2019; 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 160