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

Model Number NOT PROVIDED

Device Problem Crack (1135)

Patient Problem No Code Available (3191)

Event Date 04/03/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report.Additional information, including device details, post primary and pre revision x-rays, a detailed patient outcome and the explanted 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 requested, and upon receipt the relevant device manufacturing records will be identified and reviewed.

Event Description

Cormet revision due to a crack in the stem of the femoral head and displacement.

Manufacturer Narrative

Per -341 final report : additional information, including device details, the explanted devices, post primary and pre revision x-rays and a detailed patient outcome was requested in order to progress with the investigation.However, these details were not provided and therefore, there was only very limited information available for this investigation.The appropriate device details were not provided and thus the relevant device manufacturing records could not be identified or reviewed.The explanted devices and x-rays were not available for review.Based on this, no further investigation can be conducted and corin now consider this case closed.If further information is provided or the explanted devices are returned for examination then this case may be re-opened for further investigation.

Event Description

Cormet revision due to a crack in the stem of the femoral head and displacement.

• Brand Name: CORMET
• Type of Device: HIP RESURFACING 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: 6572108
• MDR Text Key: 75442236
• Report Number: 9614209-2017-00029
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 04/17/2017
• 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
• Treatment: CORMET RESURFACING CUP
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR