MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. SUMMIT POR TAPER SZ7 HI OFF; HIP FEMORAL STEM/SLEEVE

Catalog Number 157011135

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 04/14/2014

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.The asr platform was voluntarily recalled from the market 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 the investigation closed at this time.Should the product and/or additional information be received, the investigation will be re-opened.

Event Description

Litigation alleges that the patient suffers from pain and discomfort which has increased over time and difficulties with activities of daily living.The patient also alleges elevated levels of cobalt chromium metal ions, and muscles mass and deterioration of the soft tissue in her hip.Doi: (b)(6) 2009- dor: none reported (left side).Patient is a resident of (b)(6).Update - der rcvd - updated surgeon / hospital / product and patient information.Update rec'd 12/5/2014 - plaintiff¿s preliminary disclosure form was received.The sleeve and stem are now being added to the complaint for elevated metal ions.The existing mdr decision has been reversed and the stem has now been reported.The complaint was updated on: 12/30/2014.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, 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.(b)(4).

• Brand Name: SUMMIT POR TAPER SZ7 HI 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: 4372056
• MDR Text Key: 12922398
• Report Number: 1818910-2014-35447
• 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,Followup
• Report Date: 01/19/2015

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: 11/12/2018
• Device Catalogue Number: 157011135
• Device Lot Number: C53KH1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/19/2015
• Initial Date FDA Received: 12/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2008
• 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: 83 YR