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U.S. Department of Health and Human Services

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

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DEPUY FRANCE SAS - 3003895575 CORAIL HA W/O COLLAR S12 150MM HIP FEMORAL STEM Back to Search Results
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.
 
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Brand NameCORAIL HA W/O COLLAR S12 150MM
Type of DeviceHIP FEMORAL STEM
Manufacturer (Section D)
DEPUY FRANCE SAS - 3003895575
7 allee irene joliot-curie
b.p. 256
saint priest cedex 69801
FR 69801
Manufacturer (Section G)
DEPUY FRANCE SAS 3003895575
7 allee irene joliot-curie
b.p. 256
saint priest cedex 69801
FR 69801
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key9805871
MDR Text Key190115392
Report Number1818910-2020-07184
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042992
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
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 Received03/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberL92512
Device Lot Number1836998
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/09/2020 Patient Sequence Number: 1
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