MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 NON COL HO SIZE 13; HIP FEMORAL STEM

Model Number L20313

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

Patient Problems Foreign Body Reaction (1868); Pain (1994); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)

Event Date 11/18/2010

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

Asr revision.Reason for revision: no information.Right hip.Doi: (b)(6) 2008.Dor: (b)(6) 2010; right hip.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary: the complaint investigation concluded that the event was related to the asr platform which was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.This stem is not part of the asr family however it did form part of the joint construct.There was no allegation of deficiency with this device.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the complaint investigation concluded that the event was related to the asr platform which was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.This stem is not part of the asr family however it did form part of the joint construct.There was no allegation of deficiency with this device.

• Brand Name: CORAIL2 NON COL HO SIZE 13
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 10110900
• MDR Text Key: 193407332
• Report Number: 1818910-2020-13019
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295258049
• UDI-Public: 10603295258049
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/29/2020

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 Model Number: L20313
• Device Catalogue Number: L20313
• Device Lot Number: 1900322
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/19/2020
• Initial Date FDA Received: 06/02/2020
• Supplement Dates Manufacturer Received: 06/10/2020; 12/11/2020; 01/07/2021
• Supplement Dates FDA Received: 06/11/2020; 12/21/2020; 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASR ACETABULAR IMPLANT 52.; ASR ACETABULAR IMPLANT 52.; CORAIL2 NON COL HO SIZE 13.; CORAIL2 NON COL HO SIZE 13.; DEPUY ASR XL FEM IMP SIZE 46.; LARGE MOD HEAD ADAPT 12/14 +5.; LARGE MOD HEAD ADAPT 12/14 +5.; UNKNOWN HIP FEMORAL HEAD.; ASR ACETABULAR IMPLANT 52; CORAIL2 NON COL HO SIZE 13; LARGE MOD HEAD ADAPT 12/14 +5; UNKNOWN HIP FEMORAL HEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR