MAUDE Adverse Event Report: CORIN MEDICAL, LTD. TRINITY; ACETABULAR HIP SYSTEM

Device Problem Material Deformation (2976)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

Trinity cup and biolox delta ceramic liner revised after approximately 6 months due to "exaggerated anteversion of the cup".

Manufacturer Narrative

(b)(4) initial report: device details, explant and reason for revision have been requested in order to progress with the investigation.Device manufacturing records cannot be reviewed at this time as no device details have been provided.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.

• Brand Name: TRINITY
• Type of Device: ACETABULAR HIP SYSTEM
• Manufacturer (Section D): CORIN MEDICAL, LTD.; the corinium centre; cirencester GL7 1YJ; UK GL7 1YJ
• Manufacturer Contact: adrienne day ; the corinium centre; cirencester GL7 1-YJ ; UK GL7 1YJ ; 1285884757
• MDR Report Key: 4151532
• MDR Text Key: 4915714
• Report Number: 9614209-2014-00084
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K093472
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 10/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 MINIHIP STEM; ASSOCIATED BIOLOX DELTA CERAMIC LINER 36MM
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 62