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

Model Number 322.03.636

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

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

Event Date 07/03/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report.Additional information, including post primary and pre revision x-rays, operative notes, patient medical history and an update on the patient 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 confirmed that the patient did not experience any reported trauma prior to the dislocation and that the explanted devices cannot be returned for examination.The appropriate device details have been provided and 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 of the ecima liner and cup after approximately 2 weeks due to dislocation.

Manufacturer Narrative

Per -(b)(4) final report additional information, including post primary and pre revision x-rays, operative notes, patient medical history and an update on the patient has been requested in order to progress with the investigation of this event, however, not all could be provided and thus the scope of the investigation was limited.It was confirmed that the patient did not experience any reported trauma prior to the dislocation and that the explanted devices cannot be returned for examination.The appropriate device details have been provided and the relevant device manufacturing records have been identified and reviewed.All finished 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 and 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 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 representataive or distributor caused or contributed to this event.

Event Description

Trinity revision of the ecima liner and cup after approximately 2 weeks 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: 10306682
• MDR Text Key: 199838010
• Report Number: 9614209-2020-00056
• 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: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 322.03.636
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 452341
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRINITY CUP, PN: 321.03.350, LC: 442736; TRINITY CUP, PN: 321.03.350, LC: 442736; TRINITY CUP, PN: 321.03.350, LC: 442736
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR