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

Catalog Number UNK-HIP

Device Problems Material Disintegration (1177); Device Dislodged or Dislocated (2923); Naturally Worn (2988); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Adhesion(s) (1695); Fall (1848); Foreign Body Reaction (1868); Bone Fracture(s) (1870); Pain (1994); Pocket Erosion (2013); Discomfort (2330); Injury (2348); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 08/27/2014

Event Type  Injury  

Event Description

Litigation alleges pain, discomfort, and large amounts of toxic cobalt chromium metal ion 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

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.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 this investigation closed at this time.

Event Description

Update 9/29/15-pfs and medical records received.After review of the medical records for mdr reportability, the revision operative note indicated elevated metal ions, severe bone erosion, dislocations, and dark tissues.Before the dor the patient fell and sustained a greater trochanter fracuture.During the dor, the fracture was plated and cabeled.The stem is being added to the complaint.No part/lot information has been provided.A correct dor was provided.The complaint was updated on:10/23/2015.

Manufacturer Narrative

(b)(4).

Event Description

Ppf alleges metal wear and metallosis, s.Added law firm, revision hospital and surgeon and updated patient harm.Corrected patient identifier.There is no any reported information for the implant devices.Doi: (b)(6) 2008 - dor: (b)(6) 2015 (left hip).

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. patient code: no code available (3191) used to capture (medical device removal).

Event Description

Pfs alleges walking difficulty.After review of medical records, patient was revised to address failed left total hip arthroplasty secondary to elevated cobalt and chromium levels, including severe bone erosion.Indication note reported patient had fall, greater trochanteric fracture and dislocation.Operative note reported the trochanter was found to be anteriorly and superiorly displaced, scar tissue and minimal bone loss.

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, 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 46581 0988
• MDR Report Key: 4050483
• MDR Text Key: 4907729
• Report Number: 1818910-2014-27005
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,consumer,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2014
• 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: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 61