MAUDE Adverse Event Report: CORIN MEDICAL TRINITY ACETABULAR HIP SYSTEM WITH HXLPE LINERS TRINITY COCR MODULAR HEAD

Model Number E321.236

Device Problem Inaccurate Information (4051)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/07/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4) initial report. The appropriate device details have been provided. The relevant device manufacturing records were identified and will be reviewed. One part from each of the 2 involved batches were opened and contained the correct part. It is confirmed based on photograph that the part was packaged with the incorrect labeling. Conclusions will be provided in a supplemental report. 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

A kneetec size 2 tibial tray was labeled as trinity modular head.

• Brand Name: TRINITY ACETABULAR HIP SYSTEM WITH HXLPE LINERS
• Type of Device: TRINITY COCR MODULAR HEAD
• Manufacturer (Section D): CORIN MEDICAL; the corinium center; cirencester, gl7 1yj ; UK
• Manufacturer (Section G): CORIN MEDICAL; the corinium center; cirencester, gl7 1yj ; UK
• Manufacturer Contact: marie-anne euzen ; the corinium center; cirencester, gl7 1yj ; UK
• MDR Report Key: 11816062
• MDR Text Key: 251694181
• Report Number: 9614209-2021-00063
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K110087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/15/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: E321.236
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 408143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial