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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CORAIL2 STD SIZE 10 CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

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DEPUY ORTHOPAEDICS INC US CORAIL2 STD SIZE 10 CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM Back to Search Results
Catalog Number 3L92510
Device Problem Loss of Osseointegration (2408)
Patient Problems Rheumatoid Arthritis (1724); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Thyroid Problems (2102); Tissue Damage (2104); Anxiety (2328); Distress (2329); Injury (2348); Depression (2361); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671); Not Applicable (3189); No Code Available (3191)
Event Date 01/15/2018
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.
 
Event Description
Pinnacle litigation received. Litigation alleges pain, rheumatoid arthritis, fibromyalgia, thyroid disease, inflammatory issues, metallosis, pain caused by lumbar radiculopathy, injury and disability, lack of mobility, emotional distress, increased lucency suggestive of a loosened stem, depression, anxiety, and elevated metal ions. Doi: (b)(6) 2008; dor: (b)(6) 2018; right hip.
 
Manufacturer Narrative
Product complaint # (b)(4). Investigation summary: no device associated with this report was received for examination. A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided. Device history lot: null. Device history batch: null. Device history review: null. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
(b)(4).
 
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Brand NameCORAIL2 STD SIZE 10
Type of DeviceCORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
7000 orthopaedic drive
b.p. 256
warsaw IN 46582 0988
MDR Report Key7514595
MDR Text Key108269298
Report Number1818910-2018-59654
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
K042992
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 09/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2010
Device Catalogue Number3L92510
Device Lot Number2275475
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/11/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 05/15/2018 Patient Sequence Number: 1
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