MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. SUMMIT DUOFIX TAP SZ7 STD OFF; HIP FEMORAL STEM/SLEEVE

Catalog Number 157002135

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 03/27/2014

Event Type  Injury  

Event Description

Litigation alleges pain and discomfort.Update: 3/27/2014- sales rep reported revision surgery.Patient was revised to address pain, metallosis and elevated metal ion levels.There is no new additional information that would affect the investigation.This complaint was updated on: 04/09/2014.Update rec'd 12/1/14 - plaintiff¿s preliminary disclosure form was received, which identified dob.The sleeve and stem are being added to the complaint for elevated metal ions.The complaint was updated on: 12/30/14.

Manufacturer Narrative

The asr platform was voluntarily recalled from the market in in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions.(b)(4).Depuy considers this investigation closed at this time.Should the product and/or additional information be received, the investigation will be re-opened.(b)(4).

• Brand Name: SUMMIT DUOFIX TAP SZ7 STD OFF
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4372157
• MDR Text Key: 20019437
• Report Number: 1818910-2014-35455
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK001991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Attorney
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/01/2014

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: 04/14/2018
• Device Catalogue Number: 157002135
• Device Lot Number: CN8EE1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2014
• Initial Date FDA Received: 12/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 96