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

Model Number 921.129

Device Problems Entrapment of Device (1212); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

C-1592 initial report.This initial report is being submitted now as it was erroneously submitted as a follow-up report in error.This case was submitted as a result of a retrospective review.No adverse event reported.Additional information, including the return of the device was requested in order to progress with the investigation, but was not received.Therefore, there was only limited information available for this investigation.The appropriate device details were provided and the relevant device manufacturing records were identified and reviewed.Unfortunately the reported device was not returned to corin uk for examination, however, the possible root causes of the failure mode were discussed and it was concluded that the thread on the handle may have been damaged prior to attachment of the cup which may have led to cross threading.Based on this, corin now considers this case closed.However, should any new information be provided or if the device is returned this case may be re-opened for further investigation.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.This event occurred outside of the usa.

Event Description

The trinity std introducer/impactor handle could not be removed from the cup after cup impaction due to the black acetal handle rotating around the shaft.

• Brand Name: TRINITY
• Type of Device: ACETABULAR 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
• MDR Report Key: 5881729
• MDR Text Key: 203861048
• Report Number: 9614209-2016-00135
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K093472
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/17/2016

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: 921.129
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 059814-51
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/07/2015
• Initial Date FDA Received: 08/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1