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

Model Number 325.02.034

Device Problems Loose or Intermittent Connection (1371); Loss of Osseointegration (2408); Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problems Joint Dislocation (2374); Insufficient Information (4580)

Event Date 07/19/2022

Event Type  Injury  

Event Description

Trinity dual mobility revision of the cup, cocr liner, ecima insert and modular head after 1 day due to cup loosening and dislocation.

Manufacturer Narrative

(b)(4) initial report.Additional information, including photographs of the explanted devices, especially the coated part of the trinity cup, post primary and pre revision x-rays, operative notes (primary and revision), patient medical history, when was the cup loosening and dislocation identified, what was the patient doing at the time of the dislocation, did the patient follow correct post-op protocol, did the patient experience any slips / falls or other sort of trauma post primary, 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.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 of the cup, cocr liner, ecima insert and modular head after 1 day due to cup loosening and dislocation.

Manufacturer Narrative

Per -4903 final report.Additional information, including photographs of the explanted devices, especially the coated part of the trinity cup, post primary and pre revision x-rays, operative notes (primary and revision), patient medical history, when was the cup loosening and dislocation identified, what was the patient doing at the time of the dislocation, did the patient follow correct post-op protocol, did the patient experience any slips / falls or other sort of trauma post primary, an update on the patient post revision was requested in order to progress with the investigation of this event, however, this information could not be provided and thus the scope of the investigation was limited.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.All finished part 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 loosening and dislocation could not be identified.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
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: dardan uka ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 15109774
• MDR Text Key: 296661234
• Report Number: 9614209-2022-00061
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K170359
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 325.02.034
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 498231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: COCR EUROCONE MOD HEAD: E100.022, 373921; COCR EUROCONE MOD HEAD: E100.022, 373921; TAPERFIT STEM: 588.3801, 497728; TAPERFIT STEM: 588.3801, 497728; TRINITY CUP: 321.02.348, 443026; TRINITY CUP: 321.02.348, 443026; TRINITY DM COCR LINER: 321.02.532, 496244; TRINITY DM COCR LINER: 321.02.532, 496244
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female