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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK HIP FEMORAL STEM CORAIL

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DEPUY IRELAND - 9616671 UNK HIP FEMORAL STEM CORAIL Back to Search Results
Catalog Number UNK HIP FEMORAL STEM CORAIL
Device Problems Osseointegration Problem (3003); Migration (4003)
Patient Problems Pulmonary Embolism (1498); Stroke/CVA (1770); Bone Fracture(s) (1870); Hematoma (1884); Inflammation (1932); Sepsis (2067); Inadequate Osseointegration (2646); Physical Asymmetry (4573)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
The literature article entitled, "uncemented total hip arthroplasty in octogenarian and nonagenarian patients" written by giuseppe toro, hugo bothorel, mo saffarini, laurent jacquot, julien chouteau, and jean-charles rollier published european journal of orthopaedic surgery & traumatology published online 2 june 2018 was reviewed. The article's purpose was to compare functional outcomes and complication rates of uncemented tha in patients aged >80 to patients aged <80; and determine demographic and morphological factors that independently influence functional outcomes. Data was compiled from 411 thas in 387 patients (24 bilateral) between august 2012 and june 2015. All patients received the same depuy stem and were utilized in conjunction with one of three products: novae sunfit dual mobility, pinnacle hemispheric, or novae e th hemispheric with screws. Table 3 provides patient identifiers for patients who experienced intraoperative/post-operative periprosthetic femoral fractures/cracks. All cracks were treated with partial weight bearing and cerclage for intraoperative cracks. Table 2 provides a list of complications (categorized as generalized adverse events) but the article does not clarify if patients experienced more than one complication, therefore exact quantities cannot be determined. The article does not provide adequate information to determine accurate quantities of products involved in the generalized adverse events. Material of bearing surfaces not identified. This article reports these implants are uncemented. Figure 3 provides a radiographic image of a periprosthetic fracture repaired with cerclage. Depuy products: corail stem, pinnacle cup, liner (material unknown), head (material unknown). Serf products: novae sunfit dual mobility, novae e th hemispheric with screws (also dual mobility), poly liner for either novae sunfit or novae e th cup. Generalized adverse events of data set: leg length discrepancy (treated by revision), radiolucency and aseptic loosening (treated by revision), stem migration (treated by revision), dislocation (treatment unknown/involved products unknown), cyst (clinically associated with inflammatory response, treated by revision), cracks and periprosthetic fractures (treated by revision and anatomic location not identified), hematoma (treatment not identified), distal femoral fracture (treatment not identified), pulmonary embolism (treatment not identified), sepsis (treated by revision), stroke (treatment not identified).
 
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Brand NameUNK HIP FEMORAL STEM CORAIL
Type of DeviceFEMORAL STEM
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr
warsaw, IN 46581
6107428552
MDR Report Key11047913
MDR Text Key222764393
Report Number1818910-2020-27356
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP FEMORAL STEM CORAIL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/21/2020 Patient Sequence Number: 1
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