MAUDE Adverse Event Report: CORIN MEDICAL TRINITY; ACETABULAR HIP SYSTEM WITH ECIMA LINERS,

Model Number 322.04.636

Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problem Joint Dislocation (2374)

Event Date 10/22/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report.Additional information, including post primary and pre revision x-rays, operative notes, patient age and activity level, patient medical history and an update on the patient following the revision has been requested, and if received, will be provided in a supplemental report upon completion of the investigation.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.

Event Description

Trinity revision of the ceramic head and ecima liner after approximately 3 months due to dislocation.

Event Description

Trinity revision of the ceramic head and ecima liner after approximately 3 months due to dislocation.

Manufacturer Narrative

(b)(4) combined report.Additional information, including post primary and pre revision x-rays, operative notes, and an update on the patient following the revision have been requested, but were not provided.The explanted devices were not available to be returned for examination.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.The finished parts associated with these records conformed to dimensional and material specifications at the time of manufacture.No further investigation for this event is possible at this time as no devices and insufficient information were provided.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: 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 distrubutor caused or contributed to this event.

• Brand Name: TRINITY
• Type of Device: ACETABULAR HIP SYSTEM WITH ECIMA LINERS,
• Manufacturer (Section D): CORIN MEDICAL; the corinium center; cirencester, gl7 1yj GL7 1 YJ; UK GL7 1YJ
• MDR Report Key: 10792832
• MDR Text Key: 214799469
• Report Number: 9614209-2020-00102
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K111481
• 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: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 322.04.636
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 453542
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BIOLOX DELTA CERAMIC HEAD: 104.3605, 453778; BIOLOX DELTA CERAMIC HEAD: 104.3605, 453778; METAFIX STEM: 579.1008, 332322; METAFIX STEM: 579.1008, 332322; TRINITY CUP: 321.04.358, 443109; TRINITY CUP: 321.04.358, 443109; BIOLOX DELTA CERAMIC HEAD: 104.3605, 453778; METAFIX STEM: 579.1008, 332322; TRINITY CUP: 321.04.358, 443109
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 100