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

Model Number E321.022

Device Problems Device Markings/Labelling Problem (2911); Appropriate Term/Code Not Available (3191)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/06/2022

Event Type  malfunction  

Manufacturer Narrative

Per (b)(4) initial report.The investigation is currently in progress.The relevant device manufacturing records will be identified and reviewed.Clarification of the event was requested from the reporter.It was reported that the failure was identified during surgery.Another part was opened and implanted.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.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.

Event Description

A 28mm trinity dual mobility modular head was labelled as a 22mm.

Manufacturer Narrative

Per -4792 final report the relevant device manufacturing record of the part e321.022 was identified and reviewed.It was found that the device was manufactured in sept 2021 and conformed to specifications at the time of manufacture.In parallel, the dhr of the part e321.128 was reviewed.It was manufactured in march 2022 and conformed to specifications at the time of manufacture.The devices were not returned for examination, despite the reminders.Based on investigation, the parts e321.022 lot 487696 and e321.128 lot 501458 were "opened" for the surgery dated 06/06/22 and invoiced on 10/06/22.That would mean that both parts could have been opened at the same time at the beginning of the surgery.In addition, lot 487696 was issued 11 aug 21 and completed into stock 04 nov 21.Lot 501458 was issued 09 feb 22 and completed into stock 22 apr 22.There was no overlap in production between the 2 batches therefore it is not possible the mix up occurred in manufacturing.Based on this, corin now consider this case closed.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.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.

Event Description

A 28mm trinity dual mobility modular head was labelled as a 22mm.

• 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: dardan uka ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 14711749
• MDR Text Key: 302947721
• Report Number: 9614209-2022-00046
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K170359
• 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: 08/24/2022

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: E321.022
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 487696
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/07/2022
• Initial Date FDA Received: 06/16/2022
• Supplement Dates Manufacturer Received: 06/07/2022
• Supplement Dates FDA Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2021
• 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: TRINITY MODULAR HEAD: E321.128, 501458.; TRINITY MODULAR HEAD: E321.128, 501458.