MAUDE Adverse Event Report: CORIN MEDICAL TRINITY WITH XL HEADS; BIOLOX DELTA MODULAR HEAD

Model Number 104.3615

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 05/24/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report.Additional information, including cup device details, x-rays, operative notes, and an update on the patient following the revision have been requested to the reporter.Available information will be detailed in a supplemental report.The appropriate device details were provided.The relevant device manufacturing records will be identified and will be reviewed.Conclusions will be provided in a supplemental report.

Event Description

The patient underwent surgery fortrinity system revision due to infection: during the revision, the surgeon could not remove the trinity biolox delta ceramic head.Therefore no parts were removed.

Manufacturer Narrative

Per -3817 final report.Additional information, including cup device details, x-rays, operative notes, and an update on the patient following the revision have been requested to the reporter.Available information will be detailed in a supplemental report.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.These devices were manufactured, packaged and sterilised to the correct specifications at the time of manufacture.The sterilization method and sterile barrier system used to package trinity / metafix devices have a long history of safe and effective use at corin for a wide range of orthopaedic devices and has been validated in accordance with the relevant standards.Infection is a known complication with any invasive surgery.Based on the above, no further investigation can be conducted, and the root cause of the reported infection and why the head could not be removed could not be determined.Therefore, this case is now considered closed, however, should any additional information be provided then this case may be re-opened for further investigation.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

The patient underwent surgery for trinity/minihip system revision due to infection: during the revision, the surgeon could not remove the trinity biolox delta ceramic head.Therefore no parts were removed.

• Brand Name: TRINITY WITH XL HEADS
• Type of Device: BIOLOX DELTA MODULAR HEAD
• Manufacturer (Section D): CORIN MEDICAL; the corinium center; cirencester, GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN MEDICAL; the corinium center; cirencester, GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: marie-anne mcdonough ; 12750 citrus park lane; suite120; tampa, FL 33625
• MDR Report Key: 11896533
• MDR Text Key: 264501096
• Report Number: 9614209-2021-00070
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 12/16/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 104.3615
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 455949
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/24/2021
• Initial Date FDA Received: 05/27/2021
• Supplement Dates Manufacturer Received: 04/14/2021
• Supplement Dates FDA Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: MINIHIP STEM: PART 580.0007 LOT 464727.; TRINITY CLUSTER SHELL: PART 321.03.354 LOT 436538.; TRINITY ECIMA LINER 322.04.940 LOT 459991.; TRINITY LINER ECIMA 322.03.936 LOT 466683.; TRINITY LINER ECIMA: PART 322.03.936 LOT 466683.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male