MAUDE Adverse Event Report: CORIN MEDICAL TRINITY; HIP PROSTHESIS

Model Number 321.03.356

Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Joint Dislocation (2374)

Event Date 01/27/2020

Event Type  Injury  

Manufacturer Narrative

Per -2752 initial report.Additional information, including device lot codes, post primary and pre revision x-rays, operative notes, patient details and an update on the patient has been requested, and if received will be provided in a supplemental report upon completion of the investigation.Upon receipt of the appropriate device lot codes, the relevant device manufacturing records will be identified and reviewed.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 approximately 1 year 10 months due to liner issues.When explanting it was identified that the head was not engaged with the liner.

Manufacturer Narrative

Per 2752 final report.The operative notes were provided and it was found that the patient primary implantation was on (b)(6) 2018.The patient was revised on (b)(6) 2018, due to 3 dislocations of the patient within 3 months after the primary implant, and the trinity modular head, insert and liner were implanted.A second revision occurred, due to dislocation, on (b)(6) 2020, and the 3 trinity parts were explanted.The complaint was raised in regards to this second revision.The device details were provided and the relevant device manufacturing records have been identified and reviewed.The parts associated with these records conformed to material and dimensional specifications at the time of manufacture.The surgeon indicated in the operative notes that the hip was felt to be appropriately stable at the end of the second revision.Review of the xrays highlighted that the cup was very flat and not on the right orientation which could explain the dislocations.It was also reported that the patient had a fall that caused injury to her hip.No further investigation for this event is possible at this time, without the return of the affected device.The event is probably related to the fall of the patient.If additional relevant information becomes available to indicate further evaluation is warranted, this record will be reopened.Thus, this case is now considered closed.Please note: 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 approximately 1 year and 10 months due to liner issues.When explanting, it was identified that the head was not engaged with the liner.

• Brand Name: TRINITY
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): CORIN MEDICAL; the corinium center; cirencester; cirencester, gl7 1yj GL7 1 YJ; UK GL7 1YJ
• MDR Report Key: 9681502
• MDR Text Key: 178584781
• Report Number: 9614209-2020-00010
• Device Sequence Number: 1
• Product Code: LZO
• 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: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 321.03.356
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 357558
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DM ECIMA INSERT - 325.03.040, 354670; DM ECIMA INSERT - 325.03.040, LOT NOT PROVIDED; TRINITY MODULAR HEAD - E321.228, LOT NOT PROVIDED; TRINITY MODULAR HEAD - E321.228,313576
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR