MAUDE Adverse Event Report: CORIN LTD TRINITY; ACETABULAR SYSTEM WITH HXLPE LINERS

Model Number 321.01.628

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/22/2023

Event Type  Injury  

Manufacturer Narrative

Case-(b)(4) initial report.Additional information including the device lot codes, post primary and pre revision x-rays, whether the patient presented post primary with any complications that led to the identification of the damaged liner? (i.E.Pain, instability, dislocation etc.), patient details, whether the patient followed correct post-op protocol, whether the patient experienced any slips / falls or other trauma post primary surgery, whether some of the damage to the liner was sustained during the revision when removing the liner from the cup and an update on the patient post 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.Upon receipt of the device lot codes 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 hxlpe liner and biolox delta ceramic head after approximately 3 years and 4 months due to a damaged liner.

Manufacturer Narrative

Case-(b)(4) final report.Additional information including the device lot codes, post primary and pre revision x-rays, whether the patient presented post primary with any complications that led to the identification of the damaged liner? (i.E.Pain, instability, dislocation etc.), patient details, whether the patient followed correct post-op protocol, whether the patient experienced any slips / falls or other trauma post primary surgery, whether some of the damage to the liner was sustained during the revision when removing the liner from the cup and an update on the patient post revision was requested in order to progress with the investigation of this event, however, none of this information has been provided and thus the scope of the investigation was limited.The device lot codes have not been provided and thus the relevant device manufacturing records could not be identified or reviewed.Based on the available information, no further investigation can be conducted and the root cause of the event 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: 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: ACETABULAR SYSTEM WITH HXLPE LINERS
• Manufacturer (Section D): CORIN LTD; the corinium centre; cirencester; gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN LTD; the corinium centre; cirencester; gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: dardan uka ; the corinium centre; cirencester; gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 18316763
• MDR Text Key: 330328802
• Report Number: 9614209-2023-00276
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K110087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 321.01.628
• Device Lot Number: NOT PROVIDED
• Distributor Facility Aware Date: 12/04/2023
• Date Manufacturer Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: No
• 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: 104.2800, NOT PROVIDED.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female