MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL HA W/ COLLAR S13 155MM; CORAIL IMPLANT

Catalog Number L92503

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

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 11/05/2007

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient was revised to address pain and swelling (left side).Doi: (b)(6) 2003.Dor: (b)(6) 2007.Update ad 31 aug 2018: (b)(4) has been re-opened under (b)(4) due to pinnacle litigation record received.In addition to what was previously reported.Litigation alleges pain, discomfort, inflammation and difficulty ambulating, performing daily activities, swelling and emotional distress.Added revision surgeon name, lawyer name, udi and patient harm.Corrected manufacturing date.Doi: (b)(6) 2003.Dor: (b)(6) 2007.Left hip.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision depuy synthes 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: corrected h6 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 HA W/ COLLAR S13 155MM
• Type of Device: CORAIL IMPLANT
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 9109743
• MDR Text Key: 164629284
• Report Number: 1818910-2019-105914
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 11/05/2007

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: L92503
• Device Lot Number: 1351181
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 113