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

Model Number 322.05.636

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Joint Dislocation (2374); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/18/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report.Additional information, including post primary and pre revision x-rays, operative notes, patient details, whether the patient experienced any trauma prior to the dislocation 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 device is not available for examination.The appropriate device details have been provided and the relevant device manufacturing records will be identified and reviewed.

Event Description

Trinity revision of the ecima liner after approximately 4 months due to dislocation.

Manufacturer Narrative

Per -3810 final report additional information, including post primary and pre revision x-rays, operative notes, patient details, whether the patient experienced any trauma prior to the dislocation and an update on the patient post revision was requested in order to progress with the investigation of this event, however this infomation was not provided and thus the scope of the investigation was limited.It was reported that the explanted device is not available for examination.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.All parts associated with these records conformed to material and dimensional specification at the time of manufacture.Based on the available information, no further investigation can be conducted at the root cause of the reported dislocation could not be determined.Therefore, this case is now considered closed, however, should any additional information be provided then this case may be re-opened for further investigation.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 ecima liner after approximately 4 months 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
• MDR Report Key: 11893102
• MDR Text Key: 253132732
• Report Number: 9614209-2021-00068
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 322.05.636
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 458052
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRINITY CUP: 321.05.360, 452319; TRINITY CUP: 321.05.360, 452319; TRINITY SCREW: 321.040, 464093; TRINITY SCREW: 321.040, 464093; TRINITY SCREW: 321.050, 456109; TRINITY SCREW: 321.050, 456109
• Patient Outcome(s): Hospitalization; Required Intervention