MAUDE Adverse Event Report: CORIN MEDICAL CORMET; RESURFACING HIP SYSTEM

Model Number J179.250C

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Date 06/15/2016

Event Type  Injury  

Manufacturer Narrative

Per b)(4) initial report.Additional information, including post primary and pre revision x-rays and the return of the device has been requested in order to progress with this investigation, and if received, will be provided in a supplemental report upon completion of the investigation.The appropriate device details have been provided and the relevant device manufacturing records will be retrieved and reviewed.Please note: this report is filed with the fda due to an adverse 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

Cormet revision after approximately 11 years due to movement of the acetabular cup.

Manufacturer Narrative

Additional information, including post primary and pre revision x-rays and the return of the explanted devices was requested in order to progress with the investigation into this event, however, not all were provided to corin.The appropriate device details were provided and the relevant device manufacturing records were identified and reviewed, it was found that all parts associated with these records conformed to material and dimensional specification.The explanted devices were returned and examined at corin.Examination of these devices could not identify any gross signs of wear on the bearing surfaces of the cormet cup and head.There was evidence of possible delamination on the coated surface of the cup, if fixation of the acetabular component is lost it can cause movement of the cup and could possibly result in abraison an loss of coating.The devices were implanted for approximately 11 years and both the cormet cup and head exhibited charecteristics expected of an implant in use for this amount of time.Corin now consider this case closed.Please note: this report is filed with the fda due to an adverse 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

Cormet revision after approximately 11 years due to movement of the acetabular cup.

• Brand Name: CORMET
• Type of Device: RESURFACING HIP SYSTEM
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: lucinda gerber ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ ; 1285659866
• MDR Report Key: 6192941
• MDR Text Key: 62956683
• Report Number: 9614209-2016-00160
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P050016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2011
• Device Model Number: J179.250C
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: KCJI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ASSOCIATED CORMET HEAD 179.044, JUUP
• Patient Outcome(s): Hospitalization; Required Intervention