MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL HA W/O COLLAR S12 150MM; HIP FEMORAL STEM

Catalog Number L92512

Device Problems Use of Device Problem (1670); Malposition of Device (2616)

Patient Problems Adhesion(s) (1695); Edema (1820); Foreign Body Reaction (1868); Bone Fracture(s) (1870); Pain (1994); Tissue Damage (2104); Osteolysis (2377); Test Result (2695); No Code Available (3191)

Event Date 12/03/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

After review of medical records, patient's most recent complaints are of pain in the feeling of clicking and subluxating within the right joint.X-rays demonstrated acetabular component at approximately 75 degrees of abduction and retroverted.Proximal femoral greater trochanteric bony lysis was evident but femoral component appeared to be well intact.Metal ions demonstrated a cobalt level of 111 and chromium of 37.Mri demonstrated a periacetabular fluid collection with extension both anterior and lateral.Patient was revised to address painful right total hip arthroplasty, metallosis right total hip arthroplasty, abductor tear right hip secondary to metallosis, and proximal femoral bony lysis secondary to metallosis.Operative findings stated that the femoral component demonstrated to be in neutral anteversion but very well fixed.Significant proximal greater trochanteric ostial lysis secondary to metallosis was appreciated.Metallosis consisted of an area in the greater trochanter that extended down approximately 4 cm especially laterally along the femur.Comminution of the most proximal 2-3 cm of the greater trochanter was found secondary to metallosis, this has to be considered a pathologic fracture secondary to metallosis.The abductor mechanism demonstrated severe compromise secondary to metallosis.Posterior one half of the abductor demonstrated metallosis on the superficial and one half and was inserted into an area of greater trochanter that demonstrated comminuted bone.Acetabular component was found to be well fixed in approximately 75 degrees of abduction and 5 degrees of retroversion.Doi: (b)(6) 2005 - dor: (b)(6) 2018, right hip.

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 that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: product complaint (b)(4).Investigation summary :no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CORAIL HA W/O COLLAR S12 150MM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 9805871
• MDR Text Key: 190115392
• Report Number: 1818910-2020-07184
• Device Sequence Number: 1
• Product Code: KWA
• 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
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: L92512
• Device Lot Number: 1836998
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR