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

Model Number 325.03.040

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 09/22/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report.Additional information, including post primary and pre revision x-rays, operative notes, patient age and activity level, patient medical history, an update on the patient following the revision and whether they experienced any trauma, has been requested, and if received, will be provided in a supplemental report upon completion of the investigation.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.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 dual mobility revision after 2 months and 20 days due to hip dislocation.

Manufacturer Narrative

(b)(4) final report.Additional information, including post primary and pre revision x-rays, operative notes, patient age and activity level, patient medical history, an update on the patient following the revision and whether they experienced any trauma, was requested, however, none could be provided and thus the scope of the investigation was very limited.The appropriate device details were 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, the root cause of the reported dislocation could not be determined and no further investigation can be conducted, therefore, this case is now considered closed.However, should any additional information be provided 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.

• 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: 10655296
• MDR Text Key: 210595757
• Report Number: 9614209-2020-00086
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K170359
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 325.03.040
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 448891
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/09/2020
• Supplement Dates Manufacturer Received: 09/22/2020
• Supplement Dates FDA Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRINITY CUP - 321.03.350, 442735; TRINITY CUP - 321.03.350, 442735; TRINITY DM COCR LINER - 321.03.536, 442528; TRINITY DM COCR LINER - 321.03.536, 442528; TRINITY CUP - 321.03.350, 442735; TRINITY DM COCR LINER - 321.03.536, 442528
• Patient Outcome(s): Hospitalization; Required Intervention