MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN DEPUY FEMORAL HEAD; HIP FEMORAL HEAD

Catalog Number UNK-HIP

Device Problems Migration or Expulsion of Device (1395); Loss of Osseointegration (2408); Naturally Worn (2988); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Cardiopulmonary Arrest (1765); Pain (1994); Discomfort (2330); No Code Available (3191)

Event Date 12/01/2009

Event Type  Injury  

Manufacturer Narrative

The device associated with this report was not returned.Review of the device history records and/or a lot specific complaint database search was not possible as the product and lot code required was not provided.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, the need for corrective action was not indicated.Depuy considers the investigation closed at this time.Should the product and/or additional information be received, the investigation will be re-opened.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The device associated with this report was not returned.A search of the complaint database and/or dhr review was not possible as the product and lot code required was not provided.The investigation could not draw any conclusions regarding the reported event with the information available.Based on the inability to determine a root cause, the need for corrective action was not indicated.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

Event Description

Litigation alleges the patient suffers from pain, discomfort and toxic cobalt-chromium metal ions and particles to be released into the blood, tissue and bone.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

Update (b)(6) 2015 - pfs and medical records received.After review of the medical records for mdr reportability, the patient had a plate placed around his femoral component for a stressed portion on (b)(6) 2008.No fracture was noted.The patient then had his stem removed on (b)(6) 2009 for pain, loosening, and subsidence.There was also questionable infection, but all cultures came back negative.The patient was reimplanted on (b)(6) 2010.During the (b)(6) 2010 operation, the patient coded and went asystole.Cpr was performed and heart rate returned.The surgeon noted the patient was a little unstable, but decided not to plate the patient (as previously planned) as the patient needed to get to icu.No labs were provided for the alleged high metal ions.There was no indication was to caused the patient to go asystole.The stem is being added to the complaint.The complaint was updated on: (b)(6) 2015.

Manufacturer Narrative

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 code(s) was not provided.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.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

Depuy synthes has been informed that the catalog number and lot number is not available.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 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 caused or contributed to the potential event described in this report.H10 additional narrative: udi: (b)(4).H6 patient code: no code available (3191) used to capture medical device removal.

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.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: 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.

• Brand Name: UNKNOWN DEPUY FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 3885839
• MDR Text Key: 12076926
• Report Number: 1818910-2014-21598
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• 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: 06/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-HIP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 86