MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 UNK HIP FEMORAL STEM CORAIL

Catalog Number UNK HIP FEMORAL STEM CORAIL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Fever (1858); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Fluid Discharge (2686)

Event Date 02/25/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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 18: 81 yo female, bmi 25.4.Primary implants: pinnacle cup/unknown liner paired with depuy corail stem and depuy unknown head.Intraoperative culture: s.Aureus.Iv/oral antibiotics: yes.Revised with: pinnacle cup/unknown liner and corail stem/unknown head.".

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 FRANCE SAS 3003895575; 7 allee irene joliot curie; b.p. 256; st. priest cedex 69801 ; FR 69801
• Manufacturer (Section G): DEPUY FRANCE SAS 3003895575; 7 allee irene joliot curie; b.p. 256; st. priest cedex 69801 ; FR 69801
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14875865
• MDR Text Key: 295068515
• Report Number: 1818910-2022-12117
• 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: STRYKER CUP; STRYKER LINER; UNKNOWN CORAIL STEM; UNKNOWN DEPUY HIP FEMORAL HEAD; UNKNOWN HIP ACETABULAR LINER; UNKNOWN PINNACLE CUP; UNKNOWN PINNACLE GRIPTION CUP; ZIMMER HEAD; ZIMMER STEM
• Patient Outcome(s): Required Intervention