MAUDE Adverse Event Report: CORIN MEDICAL TRINITY ACETABULAR HIP SYSTEM WITH ECIMA LINERS

Model Number 322.03.936

Device Problems Device Dislodged or Dislocated (2923); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Joint Dislocation (2374); Insufficient Information (4580)

Event Date 01/18/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4). Additional information, including post primary and pre revision x-rays, operative notes (primary and revision), patient medical history, what was the patient doing at the time of the dislocation, whether patient experienced any slips / falls or other trauma prior to the dislocation, whether the patient followed correct post-op protocol, what the patient was revised to and an update on the patient post revision 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. It has been reported that the explanted devices are not available to return for examination. The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed. It was found that all parts associated with these records conformed to material and dimensional specification at the time of manufacture. 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. 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

Trinity revision of the cup, ecima liner and ceramic head 1 day post-op due to dislocation.

• Brand Name: TRINITY
• Type of Device: ACETABULAR HIP SYSTEM WITH ECIMA LINERS
• 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: marie-anne euzen ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 13382243
• MDR Text Key: 284617127
• Report Number: 9614209-2022-00007
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K093472
• 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: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 322.03.936
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 462873
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/28/2022 Patient Sequence Number: 1

Treatment

BIOLOX DELTA CERAMIC HEAD: 104.3605, 490413; TRINITY CUP: 321.03.352, 456933