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

Model Number 322.03.936

Device Problems Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/16/2021

Event Type  Injury  

Manufacturer Narrative

Per (b)(4) initial report.Additional information, including operative notes, patient details, whether the patient followed correct post-op protocol, what the patient was doing at the time of the dislocation 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.It has been reported that the explanted devices are not available for examination.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.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor contributed to this event.

Event Description

Trinity revision of the cup and ecima liner after 1 day due to dislocation.

Manufacturer Narrative

Per -3919 final report.Additional information, including operative notes, patient details, whether the patient followed correct post-op protocol, what the patient was doing at the time of the dislocation and an update on the patient following the revision was requested in order to progress with the investigation of this event, however, this information could not be provided and thus the scopr of the investigation was limited.It was reported that 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.A post primary and pre revision x-ray were provided and it was observed that the cup had moved position and looked to have been placed in cartilage rather than bone.Based on the available information it has been concluded that the dislocation was likely to have occurred as a result of a malpositioned cup during primary surgery and thus 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 contributed to this event.

Event Description

Trinity revision of the cup and ecima liner after 1 day due to dislocation.

• Brand Name: TRINITY
• Type of Device: ACETABULAR HIP SYSTEM WITH ECIMA LINERS
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• MDR Report Key: 12065239
• MDR Text Key: 258320216
• Report Number: 9614209-2021-00080
• 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: 07/30/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: 322.03.936
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 461156
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/16/2021
• Initial Date FDA Received: 06/25/2021
• Supplement Dates Manufacturer Received: 06/16/2021
• Supplement Dates FDA Received: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BIOLOX DELTA CERAMIC HEAD: 104.3600, 474692; BIOLOX DELTA CERAMIC HEAD: 104.3600, 474692; METAFIX COLLARED STEM: 579.0102, 411447; METAFIX COLLARED STEM: 579.0102, 411447; TRINITY CLUSTER SHELL: 321.03.350, 469865; TRINITY CLUSTER SHELL: 321.03.350, 469865; BIOLOX DELTA CERAMIC HEAD: 104.3600, 474692; METAFIX COLLARED STEM: 579.0102, 411447; TRINITY CLUSTER SHELL: 321.03.350, 469865
• Patient Outcome(s): Hospitalization; Required Intervention