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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD Back to Search Results
Catalog Number UNK HIP FEMORAL HEAD
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 01/30/2011
Event Type  Death  
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. Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications. 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. Corrective action was not indicated. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Report source is a literature article. There is limited information regarding the reported death(s). (b)(4).
 
Event Description
"literature article entitled, ¿the corail stem for the treatment of displaced femoral neck fractures - a viable alternative?¿ by derek t. Crawley, et al, published by hip international (2011), vol. 22, no. 2, pp. 243-250, was reviewed. The purpose of this study was to investigate clinical and radiographic outcomes for a cementless tapered titanium fully hydroxyapatite-coated corail stem in a consecutive cohort of 68 hip fracture patients between january 2004 and november 2007. Implanted depuy products: corail femoral stem and 28-mm self-centering depuy bipolar femoral head. All patients were treated with displaced femoral fractures with hemiarthroplasties. Results: 1 superficial wound infection- treatment unknown. 1 patient was revised due to stem migration caused by an undersized stem. 4 mispositioned stems. 1 periprosthetic fracture treated with cerclage. 6 patients had residual pain requiring no treatment. 2 radiographically identified stem migrations. There were 4 reported deaths within six weeks of hra surgery. Two were related to preexisting conditions- chronic renal failure and bleeding gastric ulcer- and are not included in this complaint. One patient died of a myocardial infarction 1-week postoperatively. Another patient with parkinson¿s disease died 10 days postoperatively from sepsis secondary to pneumonia. One patient with mental and physical comorbidities had a fall that led to recurrent dislocations. The fall was unrelated to the hemiarthroplasty. The patient died 317 days after surgery due to overwhelming pneumonia unrelated to the hemiarthroplasty. This death and fall are not included in the complaint. Captured in this complaint: corail stem infection, dislocation, fracture post-op, pain, pneumonia, myocardial infarction, migration, misposition; femoral head: dislocation, pain, pneumonia, myocardial infarction, and infection; femoral head: infection, myocardial infarction, pneumonia, pain. Corail stem, femoral head, and femoral head for death. ".
 
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Brand NameUNKNOWN HIP FEMORAL HEAD
Type of DeviceHIP FEMORAL HEAD
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
JTE WARSAW MFG SITE
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9339452
MDR Text Key166928697
Report Number1818910-2019-114353
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP FEMORAL HEAD
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 Received10/29/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/18/2019 Patient Sequence Number: 1
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