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

Model Number NOT PROVIDED

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Date 10/02/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Additional information, including device details, patient medical history, post primary and pre revision x-rays and the explant have been requested in order to progress with this investigation, and if received, will be provided in a supplemental report upon completion of the investigation.Upon receipt of the appropriate device details 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 9 years due to a loosening of the cup prosthesis.

Manufacturer Narrative

(b)(4).Additional information, including device details, patient medical history, post primary and pre revision x-rays and the explant have been requested in order to progress with this investigation, and if received, will be provided in a supplemental report upon completion of the investigation.Upon receipt of the appropriate device details 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 9 years due to a loosening of the cup prosthesis.

• Brand Name: CORMET
• Type of Device: RESURFACING HIP PROSTHESIS
• 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: 5846501
• MDR Text Key: 51145202
• Report Number: 9614209-2016-00006
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 08/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NOT PROVIDED
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: NOT PROVIDED
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 43 YR