MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 UNKNOWN DEPUY AML STEM; HIP FEMORAL STEM/SLEEVE

Catalog Number UNK-HIP

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); Inadequate Osseointegration (2646)

Event Date 08/14/2014

Event Type  Injury  

Manufacturer Narrative

This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Litigation alleges the patient suffers from pain, loosening, and metallosis.Update 2/10/2017: pfs and medical records received.After review of the medical records for mdr reportability, a correct dor was provided and a dor was provided.The revision operative note indicated pain, loose cup, and loose stem.While removing the stem, two fractures occurred.There was no mention of metallosis.The cup, 3 screws, stem are being added to the complaint.Part/lot is being updated for the liner/head.The complaint was updated on: 3/1/2017.

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).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.

Event Description

Complaint description: litigation alleges the patient suffers from pain, loosening, and metallosis.Update 2/10/2017: pfs and medical records received.After review of the medical records for mdr reportability, a correct dor was provided and a dor was provided.The revision operative note indicated pain, loose cup, and loose stem.While removing the stem, two fractures occurred.There was no mention of metallosis.The cup, 3 screws, stem are being added to the complaint.Part/lot is being updated for the liner/head.The complaint was updated on:3/1/2017 / | investigation method: the devices associated with this report were not returned.Review of the device history records and/or a lot specific complaint database search was not possible as the product and lot codes required were not provided.This matter is in litigation.Follow-up activities are being performed by the depuy legal team.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened./ | investigation summary: litigation alleges the patient suffers from pain, loosening, and metallosis.Doi: (b)(6) 2009 - dor: none reported (right hip).Patient is a resident of (b)(6).The devices associated with this report were not returned.Review of the device history records and/or a lot specific complaint database search was not possible as the product and lot codes required were 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.

• Brand Name: UNKNOWN DEPUY AML STEM
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6368558
• MDR Text Key: 68662155
• Report Number: 1818910-2017-13748
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-HIP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 88