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

Model Number 921.129G

Device Problems Material Discolored (1170); Difficult to Remove (1528)

Patient Problem No Information (3190)

Event Date 06/18/2015

Event Type  malfunction  

Manufacturer Narrative

Per -(b)(4) initial report: additional information and the return of the reported device has been requested in order to progress with the investigation of this event, 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 requested and reviewed.

Event Description

Revival proximal body trial would not dissengage correctly from the distal component.Excessive force was required to remove the trial.

Manufacturer Narrative

(b)(4) final report.This case is being submitted as a result of a retrospective review.The appropriate device details were provided and the relevant device manufacturing records were identified and reviewed.It was found that the parts associated with these records conformed to material and dimensional specification when manufactured.The instrument was examined at corin uk and the reported failure mode was verified.As a result of feedback from the field, corin have now initiated a project to look at implementing a new thread design for these instruments.Based on this, corin now considers 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

The thread on a trinity std introducer/impactor handle is broken.

• Brand Name: TRINITY
• Type of Device: ACETABULAR HIP SYSTEM
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN MEDICAL; the corinium centre; cirencester; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: lucinda gerber ; the corinium centre; cirencester; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ ; 1285659866
• MDR Report Key: 5852912
• MDR Text Key: 150854801
• Report Number: 9614209-2016-00055
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 08/08/2016

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: 921.129G
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 298481-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/24/2019
• Initial Date FDA Received: 08/08/2016
• Supplement Dates Manufacturer Received: 05/24/2019
• Supplement Dates FDA Received: 08/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other