MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 STD SIZE 8; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number 3L92507

Device Problems Corroded (1131); Degraded (1153)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Tissue Damage (2104); No Code Available (3191)

Event Date 07/24/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).Occupation: lawyer.Follow-up is being conducted to determine initial reporter contact information.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Asr surgeon confirmation form and medical records received.Scf alleges component malalignment, alval and soft tissue reaction.After review of the medical records the patient was revised to address pain, alval, metallosis and synovitis.Operative findings reported alval, metallosis, synovitis, minor corrosion at trunion and consistent acetabular retroversion.Doi: (b)(6) 2008; dor: (b)(6) 2012; left hip.

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.H10 additional narrative: corrected: g1, h6 (device).

• Brand Name: CORAIL2 STD SIZE 8
• 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 69801 ; FR 69801
• MDR Report Key: 10536081
• MDR Text Key: 207015714
• Report Number: 1818910-2020-20091
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295168737
• UDI-Public: 10603295168737
• Combination Product (y/n): N
• PMA/PMN Number: K190344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3L92507
• Device Catalogue Number: 3L92507
• Device Lot Number: 2437503
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASR ACETABULAR IMPLANT 50.; CORAIL2 STD SIZE 8.; DEPUY ASR XL FEM IMP SIZE 45.; LARGE MOD HEAD ADAPT 12/14 +5.; ASR ACETABULAR IMPLANT 50; CORAIL2 STD SIZE 8; DEPUY ASR XL FEM IMP SIZE 45; LARGE MOD HEAD ADAPT 12/14 +5
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR