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

Catalog Number 3L93711

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Weakness (2145); Injury (2348); Not Applicable (3189); No Code Available (3191)

Event Date 05/12/2017

Event Type  Injury  

Manufacturer Narrative

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.

Manufacturer Narrative

Udi(b)(4).

Event Description

Ppf alleges abductor muscle repair, metallosis and metal wear.Removed report source (other), added soft tissue injury due to metallosis and change metal poisoning to blood heavy metal increased.

• Brand Name: CORAIL2 LAT COXA VARA SIZE 11
• Type of Device: CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 7000 orthopaedic drive; b.p. 256; warsaw 46582 0988
• Manufacturer (Section G): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: chad gibson ; 7000 orthopaedic drive; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7498283
• MDR Text Key: 107719818
• Report Number: 1818910-2018-59182
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 10603295168881
• UDI-Public: 10603295168881
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2014
• Device Catalogue Number: 3L93711
• Device Lot Number: 5019125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/20/2018
• Date Device Manufactured: 12/17/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 75