MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 STD SIZE 10; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number 3L92510

Device Problems Loose or Intermittent Connection (1371); Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Inadequate Osseointegration (2646); Test Result (2695); No Code Available (3191)

Event Date 03/23/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Asr xl: right hip.Reason for revision:alval / soft tissue reaction.Doi: (b)(6) 2009 - dor: (b)(6) 2012 (right hip).

Manufacturer Narrative

Product complaint # (b)(4).(b)(4) used to capture blood heavy metal increased, medical device removal and surgical intervention.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Surgeon confirmation form received.Patient experienced pain, metallosis at the trunion, component loosening and elevated metal ion was noted.Doi: (b)(6) 2008; dor:(b)(6) 2012; right hip.

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.Product complaint # (b)(4).Investigation summary : the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.The investigation regarding the root cause(s) and/or corrective actions was conducted under mdd capa- 001226.Ongoing post market surveillance is conducted per our procedures for this product.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CORAIL2 STD SIZE 10
• 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: 9601645
• MDR Text Key: 175422270
• Report Number: 1818910-2020-02101
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295168768
• UDI-Public: 10603295168768
• Combination Product (y/n): N
• PMA/PMN Number: K042992
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2019

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: 3L92510
• Device Catalogue Number: 3L92510
• Device Lot Number: 2278968
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/06/2020
• Initial Date FDA Received: 01/17/2020
• Supplement Dates Manufacturer Received: 01/06/2020; 02/17/2020
• Supplement Dates FDA Received: 01/22/2020; 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention