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

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.

• 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 Key: 14874424
• MDR Text Key: 295035749
• Report Number: 1818910-2022-12059
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• 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 Number: UNK 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 Received: 06/30/2022
• Supplement Dates Manufacturer Received: 07/12/2022
• Supplement Dates FDA Received: 07/13/2022
• 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 Number: 1
• Treatment: UNKNOWN DEPUY HIP FEMORAL HEAD; UNKNOWN HIP ACETABULAR LINER; UNKNOWN PINNACLE GRIPTION CUP
• Patient Outcome(s): Required Intervention