MAUDE Adverse Event Report: CORIN MEDICAL TRINITY; CANCELLOUS BONE SCREW

Model Number 321.030

Device Problems Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problem Subluxation (4525)

Event Date 09/26/2022

Event Type  Injury  

Manufacturer Narrative

Per -5120 initial report.It was stated in the event report that x-rays / imaging was not available for this case.Additional information including operative notes, whether the patient followed correct post-op protocol, whether the patient experienced any slips / falls or other trauma post primary surgery, how long after primary surgery did the instability and subluxation start, whether the screw was removed and an update on the patient post revision was requested in order to progress wth the invetsigation of this event.It was confirmed that the screw was removed and the instabiltiy has been occurring for 6 months.The patient followed correct post-op protocol but is prone to falls and it is thought that this may have contributed to the instability.The other information could not be provided and thus the scope of this investigation was limited.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 revision of the ecima liner and ceramic head after approximately 2 years and 2 weeks due to subluxation, instability and protrusion of the screw.

Event Description

Trinity revision of the ecima liner and ceramic head after approximately 2 years and 2 weeks due to subluxation, instability and protrusion of the screw.

Manufacturer Narrative

Per 5120 final report.It was stated in the event report that x-rays / imaging was not available for this case.Additional information including operative notes, whether the patient followed correct post-op protocol, whether the patient experienced any slips / falls or other trauma post primary surgery, how long after primary surgery did the instability and subluxation start, whether the screw was removed and an update on the patient post revision was requested in order to progress wth the investigation of this event.It was confirmed that the screw was removed and the instabiltiy has been occurring for 6 months.The patient followed correct post-op protocol but suffers from alcoholism and is prone to falls and it is thought that this may have contributed to the instability.The other information could not be provided and thus the scope of this investigation was limited.The appropriate device details were provided, and the relevant device manufacturing records were identified and reviewed.No non-conformance or deviation from process were raised which could have contributed to the event.Based on the available information, no further investigation can be conducted, and the root cause of the reported event is considered to be external.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
• Type of Device: CANCELLOUS BONE SCREW
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester GL7 1 YJ,; UK GL7 1YJ,
• Manufacturer (Section G): CORIN MEDICAL; the corinium centre; cirencester GL7 1 YJ,; UK GL7 1YJ,
• Manufacturer Contact: dardan uka ; the corinium centre; cirencester, GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 15568640
• MDR Text Key: 301503140
• Report Number: 9614209-2022-00106
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K093472
• 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: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 321.030
• Device Catalogue Number: N/A
• Device Lot Number: 452296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2020
• 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: BIOLOX DELTA CERAMIC HEAD: 104.4010, 450168; BIOLOX DELTA CERAMIC HEAD: 104.4010, 450168; METAFIX STEM: 579.2006, 379850; METAFIX STEM: 579.2006, 379850; TRINITY CUP: 321.04.354, 452305; TRINITY CUP: 321.04.354, 452305; TRINITY ECIMA LINER: 322.04.640, 456100; TRINITY ECIMA LINER: 322.04.640, 456100
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male