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

Model Number 321.03.350

Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 08/23/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information, including x-rays, operative notes, patient medical history, patient age and activity level, if the patient experienced any trauma prior to the revision and an update following the 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 appropriate devices details have been provided and the relevant device manufacturing records will be identified and reviewed.Please note: this report is filled 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 occured 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 after approximatively 2 years and 9 months due to dislocation.

Event Description

Trinity revision after approximatively 2 years and 9 months due to dislocation.

Manufacturer Narrative

Per 5016: fda final report.The appropriate devices details have been provided and the relevant device manufacturing records have been identified and reviewed.No non conformance or deviation from process was identified which could have contributed to the event.Additional information, including x-rays, operative notes, patient medical history, patient age and activity level, if the patient experienced any trauma prior to the revision and an update following the revision, has been requested.Unfortunately not all information was available, therefore the scope of the investigation is limited.A pre-revision xray was provided.The review confirms that the head is dislocated posteriorly and suggests that the cup appears to be in an unusual position and may have moved.Therefore the rootcause of this event could not be determined.Thus, this case is now considered closed, however, should any additional information be provided then this case may be re-opened for further investigation 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.

• Brand Name: TRINITY
• Type of Device: ACETABULAR HIP SYSTEM
• 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: 15319217
• MDR Text Key: 298874778
• Report Number: 9614209-2022-00085
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K122305
• 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: 11/18/2022

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: 321.03.350
• Device Catalogue Number: N/A
• Device Lot Number: 434460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/24/2022
• Initial Date FDA Received: 08/30/2022
• Supplement Dates Manufacturer Received: 08/24/2022
• Supplement Dates FDA Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2019
• 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 MOD HEAD 104.3605 LOT 442544; BIOLOX DELTA MOD HEAD 104.3605 LOT 442544; TRIFIT TS STEM 694.0005 LOT 411545; TRIFIT TS STEM 694.0005 LOT 411545; TRINITY LINER (ECIMA) 322.03.636 LOT 434510; TRINITY LINER (ECIMA) 322.03.636 LOT 434510
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female