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

Model Number 321.02.348

Device Problems Failure to Osseointegrate (1863); Improper or Incorrect Procedure or Method (2017)

Patient Problems Inadequate Osseointegration (2646); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2022

Event Type  Injury  

Event Description

Tinity revision of the cup, screws, ecima liner and ceramic head after approximately 1 year and 6 months due to loosening of the cup.The revising surgeon commented that he thinks the cup was never stable from primary surgery and was undersized.

Manufacturer Narrative

Per (b)(4) initial report.Additional information including post primary x-rays, operative notes, whether the patient followed correct pos-op protocol, whether the patient experienced any slips / falls post primary, what size cup was implanted during the revision 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.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 caused or contributed to this event.

Manufacturer Narrative

Per -5100 final report additional information including post primary x-rays, operative notes, whether the patient followed correct pos-op protocol, whether the patient experienced any slips / falls post primary, what size cup was implanted during the revision and an update on the patient post revision was requested in order to progress with the investigation of this event, however, this information could not be provided and thus the scope of the investigation was limited.The appropriate device details were been provided and the relevant device manufacturing records have been identified and reviewed.It was found that 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 cup loosening could not be determined, however, the revising surgeon made comments about the primary cup being undersized with no in-growth.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

Tinity revision of the cup, screws, ecima liner and ceramic head after approximately 1 year and 6 months due to loosening of the cup.The revising surgeon commented that he thinks the cup was never stable from primary surgery and was undersized.

• Brand Name: TRINITY
• Type of Device: ACETABULAR HIP SYSTEM
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN MEDICAL; 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: 15500570
• MDR Text Key: 300763171
• Report Number: 9614209-2022-00102
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K093472
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2022

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: 321.02.348
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 464063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/18/2022
• Initial Date FDA Received: 09/28/2022
• Supplement Dates Manufacturer Received: 09/18/2022
• Supplement Dates FDA Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2021
• 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: 104.3205, 472606; BIOLOX DELTA CERAMIC HEAD: 104.3205, 472606; METAFIX COLLARED STEM: 579.0104, 450574; METAFIX COLLARED STEM: 579.0104, 450574; TRINITY ECIMA LINER: 322.02.932, 462092; TRINITY ECIMA LINER: 322.02.932, 462092; TRINITY SCREW: 321.035, 469892; TRINITY SCREW: 321.035, 469892; TRINITY SCREW: 321.035, 469893; TRINITY SCREW: 321.035, 469893
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male