MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL AMT COLLAR SIZE 10; HIP FEMORAL STEM/SLEEVE

Catalog Number 3L92500

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Discomfort (2330); No Code Available (3191)

Event Date 07/14/2011

Event Type  Injury  

Event Description

New etq created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint- patient was revised to address loosening of the cup due to fibrous tissue behind cup.A screw was also broken, a portion of which was left in the acetabulum.Update rec'd (b)(6) 2014 - litigation papers received.In addition to what was previously reported, litigation alleges the patient suffers from toxic cobalt-chromium metal ions, pain, discomfort, and inflammation.An unknown liner, head and stem are being added to address metal on metal allegations and metal ion levels.

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.Udi: unavailable.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.

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.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 the product and/or additional information be received, the investigation will be re-opened.

Event Description

New etq created in order to update etq (legacy system) complaint number wpc (b)(4).Reason for original complaint- patient was revised to address loosening of the cup due to fibrous tissue behind cup.A screw was also broken, a portion of which was left in the acetabulum.Update rec'd 12/5/2014: litigation papers received.In addition to what was previously reported, litigation alleges the patient suffers from toxic cobalt-chromium metal ions, pain, discomfort, and inflammation.An unknown liner, head and stem are being added to address metal on metal allegations and metal ion levels.Update ad 17 aug 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf and medical records.Ppf has no new allegation.After review of the post-operative notes it was indicated that there were metallosis, metal debris, and the cup had spun.Updated patient's initial.Added dob, hospital, surgeon, law firm, lawyer, product details, patient harm and pec.Doi: (b)(6) 2008, dor: (b)(6) 2011 (left hip).See (b)(4) for 2nd revision.

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.H10 additional narrative: udi: (b)(4).

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 codes).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: CORAIL AMT COLLAR SIZE 10
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex IN 69801 ; FR 69801
• MDR Report Key: 4371244
• MDR Text Key: 16632429
• Report Number: 1818910-2014-35401
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor,distributor,health prof
• Type of Report: Initial,Followup,Followup,Followup

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 Catalogue Number: 3L92500
• Device Lot Number: 2516040
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/26/2015
• Initial Date FDA Received: 12/30/2014
• Supplement Dates Manufacturer Received: Not provided; 09/06/2019; 12/19/2019
• Supplement Dates FDA Received: 03/10/2015; 09/17/2019; 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 82