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

Model Number 325.04.042

Device Problem Mechanical Jam (2983)

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

Event Date 02/27/2020

Event Type  Injury  

Manufacturer Narrative

Per (b)(4) initial report.Return of the reported devices has been requested in order to progress with the investigation of this event, and if received, will be examined and details will be provided in a supplemental report upon completion of the investigation.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.It was found that all finished parts associated with these records conformed to material and dimensional specification at the time of manufacture.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 occured outside of the usa.

Event Description

During surgery the trinity dual mobility cocr modular head got "jammed" in the ecima insert and would not move around freely.Alternative implants were located and implanted, however, this caused a 45-60 minute extension to the surgical procedure.Other than this there were no other reported impacts to the surgery or the patient.

Manufacturer Narrative

Per (b)(4).Final report return of the reported devices was requested in order to progress with the investigation of this event, however, it was later confirmed by the reporter that they had been lost and thus could not be returned for examination.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.It was found that all finished parts associated with these records conformed to material and dimensional specification at the time of manufacture.Without the return of the devices, no further investiagtion can be conducted and the root cause of the event has not been determined.This case is therefore considered closed, however, should any additional information be provided then this case may be re-opened for further investiagtion.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.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

During surgery the trinity cocr modular head got "jammed" in the trinity dual mobility ecima insert and did not move freely.Alternative implants were located and implanted, however, this caused a 40-60 minute extension to the surgical procedure.Other than this there were no other reported impacts to the surgery or the patient.

• Brand Name: TRINITY DUAL MOBILITY
• 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
• MDR Report Key: 9882133
• MDR Text Key: 190901477
• Report Number: 9614209-2020-00033
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K107359
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 325.04.042
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 436613
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRINITY DM COCR MOD HEAD - E321.228, 404924; TRINITY DM COCR MOD HEAD - E321.228, 404924
• Patient Outcome(s): Hospitalization
• Patient Age: 79 YR