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

Catalog Number UNK HIP FEMORAL STEM CORAIL

Device Problems Degraded (1153); Use of Device Problem (1670); Osseointegration Problem (3003)

Patient Problems Bone Fracture(s) (1870); Inadequate Osseointegration (2646); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

(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

The literature article entitled, "mid-term progressive loosening of hydroxyapatite-coated femoral stems paired with a metal-on-metal bearing" written by trevor gascoyne, bryan flynn, thomas turgeon, and colin burnell published by journal of orthopaedic surgery and research (2019) was reviewed.The article's purpose was to examine possible causes and associated risk factors for mid-term (3-7 years post-surgery) aseptic loosening of ha-coated femoral stems and to detail their clinical manifestation through radiographic and implant retrieval analysis.Data was compiled from 46 retrieved depuy corail stems (retrieved implants revised between 2007 and 2015) - 14 standard and 32 collard designs.Three study groups created based on bearing material: mom (qty 10); mop (qty 24) and coc (qty 12).The article later identifies the bearing surfaces to be pinnacle mom for the mom group.Results were aseptic loosening of stem associated more with mom bearing surfaces and removal of proximal ha coating was strongly associated with taper corrosion score.Article reports head size, head offset, collared stem, and patient age were not associated with aseptic loosening.Figure 1 provides radiographic imaging of a loose stem.Figure 2 provides photographic images of explanted stem with taper corrosion.Depuy product: corail stem, pinnacle cup, pinnacle metal liner, metal femoral head (assumed to be depuy utilized with pinnacle liner).Adverse events: figure 2 identifies taper corrosion on stem.Revision for aseptic loosening of stem (qty 17).Revision for infection (qty 13).Revision for high metal ions (qty 1) - associated with mom wear.Revision for periprosthetic femoral fracture (qty 13).Revision for instability/malposition (qty 1) - no further information provided.Revision for dislocation (qty 1) - not associated with stem.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Review of the attached images 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: 11055643
• MDR Text Key: 225730340
• Report Number: 1818910-2020-27441
• Device Sequence Number: 1
• Product Code: KWY
• 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: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• 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
• Date Manufacturer Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention