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

Model Number 325.03.040

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/21/2022

Event Type  Injury  

Manufacturer Narrative

Per (b)(4) initial report.Additional information, including post primary and pre revision x-rays, operative notes, whether the patient followed correct post-op protocol, what the patient was doing at the time of the fracture, 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.The explanted devices are not available to return 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 dual mobility revision of the ecima insert and trinity biolox delta ceramic head on the same day as primary surgery due to a femur fracture being discovered 4 hours post-op.A non-corin stem was also revised.

Event Description

Trinity dual mobility revision of the ecima insert and trinity biolox delta ceramic head on the same day as primary surgery due to a femur fracture being discovered 4 hours post-op.A non-corin stem was also revised.

Manufacturer Narrative

Per -4606 final report.Additional information, including post primary and pre revision x-rays, operative notes, whether the patient followed correct post-op protocol, what the patient was doing at the time of the fracture, and an update on the patient post revision was requested in order to progress with the investigation of this event, however, this information has not been provided and thus the scope of the investigation was limited.The explanted devices were not available to return for examination.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, no further investigation can be conducted and the root cause of the reported fracture could not be determined.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
• Manufacturer (Section G): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: marie-anne euzen ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 13977057
• MDR Text Key: 288380638
• Report Number: 9614209-2022-00021
• 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: 04/08/2022

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: 495127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/23/2022
• Initial Date FDA Received: 04/01/2022
• Supplement Dates Manufacturer Received: 03/23/2022
• Supplement Dates FDA Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2022
• 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: BIOLOX DELTA CERAMIC HEAD: 104.2805, 498934; BIOLOX DELTA CERAMIC HEAD: 104.2805, 498934; TRINITY CUP: 321.03.350, 486420; TRINITY CUP: 321.03.350, 486420; TRINITY DM COCR LINER: 321.03.536, 492487; TRINITY DM COCR LINER: 321.03.536, 492487
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female