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

Model Number 322.03.636

Device Problem Noise, Audible (3273)

Patient Problem No Code Available (3191)

Event Date 01/27/2020

Event Type  Injury  

Manufacturer Narrative

Per (b)(4) initial report.Additional information, including device details, confirmation on which devices were explanted, post primary and pre revision x-rays, operative notes, patient details, patient medical history, an update on the patient and return of the explanted devices 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.Upon receipt of the appropriate device details the relevant device manufacturing records will be identified and reviewed.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

Trinity revision due to rubbing noises.

Manufacturer Narrative

Per -2766 final report.In order to progress with the investigation of this event, confirmation of which devices have been revised, return of the explanted devices, post primary and pre revision x-rays, operative notes, patient medical history, patient activity level and an update on the patient was requested, however, this information has not been provided and thus the investigation of this event was very limited.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.Based on the available information, the root cause of this event has not been determined and no further investigation can be conducted and thus this case is now considered closed.However, should additional information become available then this case may be re-opened for further investigation.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

Trinity / minihip revision due to the patient experiencing rubbing noises since (b)(6) 2019.It is unknown which of the reported devices were revised.

• 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
• MDR Report Key: 9738930
• MDR Text Key: 188694360
• Report Number: 9614209-2020-00020
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K111481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2018
• Device Model Number: 322.03.636
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 257671
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BIOLOX CERAMIC HEAD - 104.3610, 253049; BIOLOX DELTA CERAMIC HEAD - DEVICE DETAILS UNKNOWN; MINIHIP STEM - 580.0003, 259727; MINIHIP STEM - DEVICE DETAILS UNKNOWN; TRINITY CUP - 321.03.354, 254234; TRINITY CUP - DEVICE DETAILS UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR