MAUDE Adverse Event Report: DEPUY IRELAND 9616671 CORAIL AMT COLLAR SIZE 12; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number 3L92502

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/06/2020

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

The implant was introduced by hand into the femur and then was impacted for the final stages using the handle.After the implant was seated into the bone the foreign body was noticed at the shoulder of the implant.At that stage the surgeon felt it was unsafe to remove the implant fearing of a fracture.He decided to keep the implant in situ accepting the fact that the foreign material was packed with the implant and therefore it was sterile.No known injury.The implant had been through sterilisation process so he assumed the cotton bud was sterile and therefore causing no harm.

Manufacturer Narrative

Product complaint #
=
> (b)(4).This product was reported in error since mrn 1818910-2020-23098 was found to be a duplicate report of mrn 1818910-2020-22872.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

• Brand Name: CORAIL AMT COLLAR SIZE 12
• Type of Device: CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 10720001
• MDR Text Key: 212551478
• Report Number: 1818910-2020-23098
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295168683
• UDI-Public: 10603295168683
• Combination Product (y/n): N
• PMA/PMN Number: K042992
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3L92502
• Device Catalogue Number: 3L92502
• Device Lot Number: 5365800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1