MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CORAIL2 STD SIZE 11; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Catalog Number 3L92511

Device Problems Corroded (1131); Degraded (1153); Metal Shedding Debris (1804)

Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Discomfort (2330)

Event Date 09/17/2012

Event Type  Injury  

Manufacturer Narrative

This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.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 cup loosening.

Manufacturer Narrative

New etq record created in order to update etq (legal system) complaint number (b)(4).Reason for original complaint ¿ patient was revised to address cup loosening.Update jul 8, 2016 litigation received.The litigation received alleges the patient suffers from pain, discomfort, elevated ion levels, metallosis, extensive corrosion of neck and taper, popping noises in the hip region, infection, inflammation, and dislocation.Examination of the reported devices was not possible as they were not returned.A search of the complaints databases finds no other reports against the provided product and lot code combination.A search of the complaints databases and/or a review of device history records were not possible as the remaining product/lot code combinations were not provided.The investigation can draw no conclusion regarding the reported event with the information available.Based on the inability to determine root cause, the need for corrective action has not been indicated.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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 : 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.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.

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: CORAIL2 STD SIZE 11
• Type of Device: CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 5839980
• MDR Text Key: 50933140
• Report Number: 1818910-2016-24343
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K123991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 3L92511
• Device Lot Number: 1863772
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 62