MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM

Catalog Number UNK HIP FEMORAL STEM

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cardiac Arrest (1762); Fatigue (1849); Pain (1994); Limited Mobility Of The Implanted Joint (2671)

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.(b)(6).

Event Description

Patient communication received.As stated,"i'm not sure what to check above.I had a full hip replacement in (b)(6) 2006.For two months now, i have been having pain in my hip.I had a depuy acetabular cup as my implant.This isn't the metal on metal implant.However, i am developing severe mobility problems and daily pain.I saw an ortho hip specialists two weeks ago and am going back to him next week.I had x-rays taken and there is a cloud around the hip implant.I don't want to go through another operation but might have to and would like to report this problem in case others are having the same from the same implant the acetabular cup model 6 mm.How do i keep you posted of the status of my severe hip pain? trying to report my problem in case other are having the same.Not sure if this section pertains to operation but it was on 2006.I have all medical records from the hospital in case you would like to see." the patient's blood is contaminated with cobalt and chromium, have develop cysts on hip implant, had a heart attack last 2017, blurry eyes and fatigue.The femoral head lot# 2236798, part# 136523000, expiration date 9/30/2011.The patient had the initial surgery on (b)(6) 2006.Doi: (b)(6) 2006 - dor: none reported (unknown hip).

Manufacturer Narrative

Product complaint #: (b)(4).Medwatch verbiage: this is a duplicate report of pc-000107743.(b)(4) is being retracted as it is a report duplication.(b)(4) will be kept for investigation purposes.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 5743725905
• MDR Report Key: 7854736
• MDR Text Key: 119495614
• Report Number: 1818910-2018-68659
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 08/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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