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

Catalog Number UNK HIP FEMORAL STEM CORAIL

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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

Article entitled "mid-term clinical and radiographic outcomes of a long cementless monobloc stem for revision total hip arthroplasty" written by jean-christophe chatelet, md, tarik ait-si-selmi, md, alain machenaud, md, sonia ramos-pascual, meng, phd, and michel-henri fessy, md, phd published by the journal of arthroplasty published online/accepted by publisher july 22, 2020 was reviewed.The article¿s purpose is to assess clinical and radiographic outcomes, as well as survival, of this long tapered cementless revision stem (corail), fully coated with ha, at a minimum follow-up of 5 years.347 hips were revised between 2000-2012 with corail revision stem (kar).The manufacturer of the products revised were not noted.Ceramic head was used in 258 hip, metal head was used in 77 hips, and unspecified head material was used in 12 hips.A variety of cups and liners were used, but none the manufactures were noted to be depuy-synthes.Of the 347 hips ¿ 77 hips the patient died (no indication of product involvement), 25 hips were lost during follow-up, 24 hips refused, and 10 hips had a re-revision of the stems (captured below).Final cohort included 211 hips.Mean follow-up was done at 9.9 years.Findings for final cohort: 38 hips had radiolucent lines around the stem (no interventions noted).7 hips had >5mm of stem migration (no interventions noted).Re-revisions (10 hips).Patient 1: (b)(6) year-old (male) revision due to aseptic stem loosening (stem only revised).Patient 2: (b)(6) year-old (female) revision due to aseptic stem loosening (stem only revised).Patient 3: (b)(6) year-old (female) revision due to deep sepsis (stem only revised).Patient 4: (b)(6) year-old (male) revision due to periprosthetic fracture (stem only revised).Patient 5: (b)(6) year-old (male) revision due to deep sepsis (stem and cup revised).Patient 6: (b)(6) year-old (female) revision due to periprosthetic fracture (stem and cup revised).Patient 7: (b)(6) year-old (female) revision due deep sepsis with aseptic loosening (stem and cup revised).Patient 8: (b)(6) year-old (male) revision due deep sepsis with aseptic loosening (stem and cup revised).Patient 9: (b)(6) year-old (female) revision due deep sepsis with aseptic loosening (stem and cup revised).Patient 10: (b)(6) year-old (female) revision due deep sepsis with aseptic loosening (stem and cup revised).Depuy products: corail cementless revision stem (kar).Depuy femoral head (various materials used).

Manufacturer Narrative

Product complaint # : pc-(b)(4).Investigation summary : no device associated with this report was received for examination.A review of the attached images could not confirm the reported allegations against this device.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.

• Brand Name: UNK HIP FEMORAL STEM CORAIL
• Type of Device: FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11165136
• MDR Text Key: 248571117
• Report Number: 1818910-2021-01000
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM CORAIL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/06/2021
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 04/01/2021
• Supplement Dates FDA Received: 04/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1