MAUDE Adverse Event Report: CORIN MEDICAL METAFIX COLLARED; HIP STEM (COLLARED)

Model Number 579.0103

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 09/07/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4) initial report.The appropriate device details have been provided and the relevant device manufacturing records will be identified and reviewed.The reported stem is being returned to corin for examination and details of the review will be provided in a supplemental report upon completion of the investigation.Please note: this report is filed with the fda due to an event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.

Event Description

The size 3 metafix stem was reported to be too loose when in the prepared femoral canal and thus the surgeon changed to a cemented stem.

Manufacturer Narrative

Per -3167 final report.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.All finished parts associated with these records conformed to material and dimensional specification at the time of manufacture.It has been reported to corin that the surgeon stated, due to poor bone quality the stem was not rotationally stable and thus they decieed to removed the stem and implant a cemented stem to improve stability.This event is not linked to the design or performance of the corin device and thus this case is now considered closed.Please note: this report is filed with the fda due to an event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.

Event Description

The size 3 metafix collared stem was reported to be too loose when in the prepared femoral canal and thus the surgeon changed to a cemented stem.

• Brand Name: METAFIX COLLARED
• Type of Device: HIP STEM (COLLARED)
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• MDR Report Key: 10618570
• MDR Text Key: 213920721
• Report Number: 9614209-2020-00081
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K153381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

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 Model Number: 579.0103
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 441001
• Initial Date Manufacturer Received: 09/07/2020
• Initial Date FDA Received: 10/02/2020
• Supplement Dates Manufacturer Received: 09/07/2020
• Supplement Dates FDA Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1