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

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).

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.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803. This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date. This report does not reflect  a conclusion by fda, depuy synthes or its employees caused or contributed to the potential event described in this report.

Event Description

After review of medical records, patient was revised to address failed implants. Revision notes reported that the stem has a clear movement of the proximal portion. The stem came out quite easily. Th proximal femoral endosteum had a quite a bit of fibrous tissue which was thoroughly cleaned. The anterior most screw was slightly stripped. When the screws came out with two turns, it became completely stripped. The posterior screw was removed with ease. Added height and weight of patient. Updated patient harm. Doi: (b)(6) 2008 - dor: (b)(6) 2018. Right hip.

• Brand Name: CORAIL2 STD SIZE 10
• Type of Device: CORAIL 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 Key: 7514595
• Report Number: 1818910-2018-59654
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295168768
• UDI-Public: 10603295168768
• Combination Product (y/n): N
• PMA/PMN Number: K042992
• Number of Events Reported: 1
• 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 Received: 05/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 11/30/2010
• Device Catalogue Number: 3L92510
• Device Lot Number: 2275475
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Age: 60 YR
• Patient Weight: 82
• Patient Outcome(s): Required Intervention