MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 CORAIL2 STD SIZE 11; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Catalog Number 3L92511

Device Problems Material Rupture (1546); Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 12/09/2008

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

Revision surgery due to the rupture of the upper edge of the ceramic insert.

Manufacturer Narrative

(b)(4).Investigation summary: no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CORAIL2 STD SIZE 11
• Type of Device: CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; b.p. 256; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; b.p. 256; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; b.p. 256; west chester, PA 19380-XXXX ; 6103142063
• MDR Report Key: 8156430
• MDR Text Key: 130163958
• Report Number: 1818910-2018-77916
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295168775
• UDI-Public: 10603295168775
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K042992
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2018

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 Expiration Date: 07/22/2013
• Device Catalogue Number: 3L92511
• Device Lot Number: 2668655
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2018
• Initial Date FDA Received: 12/12/2018
• Supplement Dates Manufacturer Received: 01/17/2019
• Supplement Dates FDA Received: 01/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2008
• Is the Device Single Use?: Yes
• 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: 47 YR