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

Model Number 322.04.940

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Fall (1848); Joint Dislocation (2374)

Event Date 10/12/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4) combined report.It was reported that following primary surgery the patient fell and dislocated which resulted in a closed reduction.Following this the patient had another fall and second dislocation so the surgeon decided to revise the trinity ecima liner and implant an elevated wall liner.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.All parts associated with these records conformed to material and dimensional specification at the time of manufacture.As the dislocation and subsequent revision was the result of the patient falling post-op, no further investigation is required and this case is now considered closed.

Event Description

Trinity revision of the ecima liner after 13 days due to the patient falling and dislocating.

• 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
• Manufacturer (Section G): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: sean moule ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 10778947
• MDR Text Key: 214395444
• Report Number: 9614209-2020-00099
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/03/2020

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: 322.04.940
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 457056
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2020
• 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: TRINITY BONE SCREW - 321.040, 417720; TRINITY BONE SCREW - 321.045, 425353
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR