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

Model Number 322.03.636

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 10/27/2020

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 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 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 5 years and 10 months due to dislocation.

Manufacturer Narrative

Per -3282 final 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 was requested in order to progress with the investigation of this event, however, not all could be provided and thus the scope of this investigation was limited.The explanted devices could not be returned for examination.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.All finished parts associated with these records conformed to material and dimensional specification at the time of manufacture.Based on the available information, no further investigation can be conducted and the root cause of the reported dislocation 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.

Event Description

Trinity revision of the ceramic head and ecima liner after approximately 5 years and 10 months due to dislocation.

• Brand Name: TRINITY
• Type of Device: ACETABULAR HI SYSTEM WITH ECIMA LINERS
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• MDR Report Key: 10799317
• MDR Text Key: 215026225
• Report Number: 9614209-2020-00103
• 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: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/23/2019
• Device Model Number: 322.03.636
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 291460
• Date Manufacturer Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BIOLOX DELTA CERAMIC HEAD: 104.3600, 290162; BIOLOX DELTA CERAMIC HEAD: 104.3600, 290162; TRINITY CUP: 321.03.352, 289431; TRINITY CUP: 321.03.352, 289431; BIOLOX DELTA CERAMIC HEAD: 104.3600, 290162; TRINITY CUP: 321.03.352, 289431
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR