MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL AMT COLLAR SIZE 11; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Catalog Number 3L92501

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Pain (1994); Swelling (2091); Tissue Damage (2104); Anxiety (2328); Depression (2361); Test Result (2695); Fibrosis (3167); No Code Available (3191)

Event Date 01/23/2018

Event Type  Injury  

Manufacturer Narrative

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.(b)(4).

Event Description

Litigation alleges elevated metal ions.Doi: (b)(6) 2010, dor: (b)(6) 2018, left hip.

Event Description

Pfs alleges walking difficulty, depression, anxiety and stress.After review of medical records, patient was revised to address metallosis left total hip replacement.On (b)(6) 2018, there was moderate inflammation in the joint and periarticular tissues were present.Some synovial debris were also cleaned from the femoral component.The result of soft tissue pathology also showed minimal inflammation, fibrosis and fibrinous exudate.

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.  udi: (b)(4).

• Brand Name: CORAIL AMT COLLAR SIZE 11
• Type of Device: CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
• 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: 8267135
• MDR Text Key: 133733190
• Report Number: 1818910-2019-81758
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295168676
• UDI-Public: 10603295168676
• Combination Product (y/n): N
• PMA/PMN Number: K042992
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2014
• Device Catalogue Number: 3L92501
• Device Lot Number: 5010234
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 57