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

Model Number 325.03.040

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

Patient Problem Unspecified Infection (1930)

Event Date 04/07/2022

Event Type  Injury  

Event Description

Trinity dual mobility revision of the ecima insert and trinity biolox delta ceramic head after 2 weeks and 2 days due to infection.The patient had a washout and a head and liner change.

Manufacturer Narrative

Per (b)(4) initial report: it was reported that the patient had experienced a fall post primary surgery which resulted in the surgical wound opening up and a wound dehiscene to occur.The patient did not tell anyone about the fall / wound for four days and subsequently got an infection.Additional information including x-rays, patient medical history and medical / operative notes 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.

Event Description

Trinity dual mobility revision of the cocr liner, ecima insert and trinity biolox delta ceramic head after 2 weeks and 2 days due to infection.The patient had a washout and a head and liner change.

Manufacturer Narrative

Per -4654 final report.It was reported that the patient had experienced a fall post primary surgery which resulted in the surgical wound opening up and a wound dehiscene to occur.The patient did not tell anyone about the fall / wound for four days and subsequently got an infection.Additional information including x-rays, patient medical history and medical / operative notes was requested in order to progress with the investigation of this event, however, no other information could be provided.The appropriate device details have been provided and the relevant device manufacturing records will be identified and reviewed.It was found that all finished parts associated with these records were manufactured, packed and sterilized to the correct specifications at the time of manufacture.It has been concluded that the root cause of this event was the patient experiencing a fall post primary which caused the surgical wound to open and become infected.Therefore, this case is now considered closed.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: marie-anne euzen ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 14103180
• MDR Text Key: 289201993
• Report Number: 9614209-2022-00026
• 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: 04/13/2022

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: 494114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/08/2022
• Initial Date FDA Received: 04/13/2022
• Supplement Dates Manufacturer Received: 04/08/2022
• Supplement Dates FDA Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2021
• 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: 104.2800, 490288; BIOLOX DELTA CERAMIC HEAD: 104.2800, 490288; TRINITY CUP: 321.03.352, 478039; TRINITY CUP: 321.03.352, 478039; TRINITY DM COCR LINER: 321.03.536, 486451; TRINITY DM COCR LINER: 321.03.536, 486451
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 114 KG