MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 STD SIZE 11; HIP FEMORAL STEM/SLEEVE

Catalog Number 3L92511

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Discomfort (2330); Test Result (2695); No Information (3190)

Event Date 01/19/2015

Event Type  Injury  

Event Description

Litigation alleges the patient suffers from pain and discomfort.Update 7/1/15-pfs and medical records received.Pfs now alleges high metal ions.After review of the medical records for mdr reportability, the stem is being reported for the alleged high metal ions.No labs provided.Part/lot is being updated.The complaint was updated on: 7/28/2015.

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

Conclusion and justification status for mdr: no device associated with this report was received for examination.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.

Event Description

Litigation alleges the patient suffers from pain and discomfort.Update 7/1/2015-pfs and medical records received.Pfs now alleges high metal ions.After review of the medical records for mdr reportability, the stem is being reported for the alleged high metal ions.No labs provided.Part/lot is being updated.The complaint was updated on: 7/28/2015.Update 11/10/2015 medical records received.After review of the medical records for mdr reportability, there is no new additional information that would affect the existing investigation.The complaint was updated on:12/1/2015.Update 12/28/2015 medical records received.Information received was for left hip.There is no new additional information that would affect the existing investigation.The complaint was updated on: jan 15, 2016.Update ad 13 jul 2018: (b)(4) has been reopened under (b)(4) due to receipt of ppf and sticker sheets record.Ppf has no new allegations reported.There is no new information provided.Doi: (b)(6) 2009- dor: none reported (right hip).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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.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 was identified.Monitor ¿ exempt per wi-7915 - known possible complication of joint replacement surgery.No device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found additional related reports against the provided product code, lot number combination.A device history record (dhr) review was conducted previously on (b)(4).The dhr analysis of the batch provided shows an initial conformance of this product with regards to its specification.For this batch, there was no deviation or non-conformance.The reported event is considered one of the possible complications of joint replacement.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.Follow-up for additional event information, if applicable, was conducted utilizing work instruction wi-7915 appendix a.Without the physical complaint sample associated with this report, it was not possible to determine if the device failed to meet specifications at the time it was released for distribution.The device associated with this event was 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 evidence was found indicating product error was a contributing factor.The need for corrective action was not indicated.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot =5011261.Device history review: a device history record (dhr) review was conducted previously on (b)(4).The dhr analysis of the batch provided shows an initial conformance of this product with regards to its specification.For this batch, there was no deviation or non-conformance.

• Brand Name: CORAIL2 STD SIZE 11
• 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 69801 ; FR 69801
• MDR Report Key: 4946301
• MDR Text Key: 19501275
• Report Number: 1818910-2015-26703
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: PK042992
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Type of Report: Initial,Followup
• Report Date: 01/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2014
• Device Catalogue Number: 3L92511
• Device Lot Number: 5011261
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 86