MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. US 1818910 BROACH CORAIL AMT 9; HIP INSTRUMENTS : BROACHES

Catalog Number L20409

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/01/2018

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

We have been notified by the surgeon, (b)(6), that they have just compiled statistics of all trauma hips done with our corail cemented stems since we got contract.This study includes all (b)(6).Their study includes around 340 hips and show femur fractures of 10 to 12% while doing the corail cemented.According to the doctor, the norm is 2 to 3%.I am still awaiting to talk to him to get more details on their study.It also includes one more hospital in (b)(6).We are reporting this info for now and should be getting more info soon.The problem seems to be a greater number of fractures of the femur while impacting the broach and also while trialing the implants.Please note that in product description i have entered only 1 sz but it includes many different sizes.Patient consequence? :yes.Patient consequence description:a little longer surgery.Action taken for procedure:fractures required circling of femurs.

Manufacturer Narrative

(b)(4).No device was returned.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: BROACH CORAIL AMT 9
• Type of Device: HIP INSTRUMENTS : BROACHES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. US 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. US 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 7968998
• MDR Text Key: 123817822
• Report Number: 1818910-2018-72621
• Device Sequence Number: 1
• Product Code: HTQ
• UDI-Device Identifier: 10603295258117
• UDI-Public: 10603295258117
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: L20409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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