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

Model Number 322.05.836

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

Patient Problem Failure of Implant (1924)

Event Date 11/20/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report.Additional information, including post primary and pre revision x-rays, operative notes, patient details and an update on the patient following the revision was requested, however, this information could not be provided and thus the scope of the investigation was limited.The appropriate device details were 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 ecima liner after approximately 2 weeks due to dislocation.

Event Description

Trinity revision of the ecima liner and biolox delta ceramic head after 16 days due to dislocation.

Manufacturer Narrative

Per -3342 final report.Additional information, including post primary and pre revision x-rays, operative notes, patient details and an update on the patient following the revision was requested, however, this information could not be provided and thus the scope of the investigation was limited.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, the root cause of the reported dislocation could not be determined and no further investigation can be conducted.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 HIP SYSTEM WITH ECIMA LINERS
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• MDR Report Key: 10958474
• MDR Text Key: 219986911
• Report Number: 9614209-2020-00121
• 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: 02/16/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: 322.05.836
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 449950
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 12/07/2020
• Supplement Dates Manufacturer Received: 11/20/2020
• Supplement Dates FDA Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BIOLOX DELTA CERAMIC HEAD - 104.3610, 455262; BIOLOX DELTA CERAMIC HEAD - 104.3610, 455262; METAFIX COLLARED STEM - 579.2105, 453585; METAFIX COLLARED STEM - 579.2105, 453585; TRINITY CUP - 321.05.360, 448872; TRINITY CUP - 321.05.360, 448872; BIOLOX DELTA CERAMIC HEAD - 104.3610, 455262; METAFIX COLLARED STEM - 579.2105, 453585; TRINITY CUP - 321.05.360, 448872
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR