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 Problem Physical Asymmetry (4573)

Event Date 09/29/2020

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

Literature article entitled, ¿operative technique: autologous impaction bone grafting with uncemented corail stem in primary total hip arthroplasty ¿by jami ilyas, mbbs, mrcs, pg dip surgical anat, et al, published by techniques in orthopaedics (2019), vol.34, no.1, pp.53-57, was reviewed.The purpose of this article was to describe a novel surgical technique utilizing the patient¿s own femoral head as autogenic cancellous bone graft in the proximal femur in primary thas for 50 patients.All 50 patients received a depuy corail stem.The manufacturers of the cups, heads, and liners were not specified.This complaint will capture the results associated with the depuy corail stem.1 superficial infection with wound ooze and hematoma treated with hematoma evacuation, dressing debridement, and oral antibiotics.No revisions performed.1 stem revision to treat unspecified symptomatic limb asymmetry.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Examination of the attached photos could not confirm the reported complaint.A root cause could not be determined.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.Corrected: d3.

• 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
• MDR Report Key: 11086903
• MDR Text Key: 224052985
• Report Number: 1818910-2020-27699
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/10/2020

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
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 03/01/2021
• Supplement Dates FDA Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention