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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Impaired Healing (2378)
Event Date 02/25/2022
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
"this complaint is from a literature source.The following literature cite has been reviewed: riemer k, lange j.Early periprosthetic hip joint infection managed by cementless one-stage revision - a case series.J bone jt infect.2022 feb 25;7(1):43-50.Doi: 10.5194/jbji-7-43-2022.Pmid: 35251904; pmcid: pmc8892566.Objective and methods: the purpose of this study is to evaluate the effectiveness of cementless one-stage revision for early periprosthetic joint infection (pji) in elective primary total hip arthroplasty (tha) regarding risk of re-operation with exchange of implants in 18 patients between january 2012 and march 2018.Early pji is defined as confirmed infection within 6 weeks of primary tha with clinical signs of fever, erythema, wound drainage, and pain, lab results of elevated crp, leukocytosis, and positive cultures, and direct fistulation (deep infection) to the joint.All stage 1 revisions followed the coriha protocol requiring extensive biofilm debridement during revision, drape and instrumentation changes, patient re-sterilization between removal and implantation, and no use of drains or pain catheters.All patients retained their revision devices by end of follow-up.Patient 5: (b)(6) female, bmi 27.5.Primary implants: competitor cup/liner paired with depuy corail stem and depuy unknown head.Intraoperative culture: unspecified.Iv/oral antibiotics: yes.Revised with: pinnacle gription cup/unknown liner and corail stem/unknown head.After revision, patient had prolonged wound healing requiring a i&d, all products were retained.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
 
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Brand Name
UNK HIP FEMORAL STEM CORAIL
Type of Device
FEMORAL 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
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key14874424
MDR Text Key295035749
Report Number1818910-2022-12059
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
Reporter Country CodeDA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK HIP FEMORAL STEM CORAIL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/22/2022
Initial Date FDA Received06/30/2022
Supplement Dates Manufacturer Received07/12/2022
Supplement Dates FDA Received07/13/2022
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 Number1
Treatment
UNKNOWN DEPUY HIP FEMORAL HEAD; UNKNOWN HIP ACETABULAR LINER; UNKNOWN PINNACLE GRIPTION CUP
Patient Outcome(s) Required Intervention;
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