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

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.".

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP 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 Key: 9339452
• MDR Text Key: 166928697
• Report Number: 1818910-2019-114353
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• 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 Received: 11/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2019
• 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 Sequence Number: 1
• Patient Outcome(s): Death