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

Model Number 321.03.350

Device Problems Device Dislodged or Dislocated (2923); Positioning Problem (3009)

Patient Problem Joint Dislocation (2374)

Event Date 08/16/2021

Event Type  Injury  

Manufacturer Narrative

Per (b)(4) initial report.Additional information including x-rays, operative notes, patient medical history, what the patient was doing at the time of the dislocation, whether the patient followed correct post-op protocol 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.

Event Description

Trinity revision of the biolox delta ceramic head and a cancellous bone screw on the same day as primary surgery due to dislocation.The reporter stated that the dislocation was due to the positioning of the cup at primary.Please note: the ceramic liner associated with this report is not cleared for sale or distribution within the usa and this event occurred outside of the usa.

Manufacturer Narrative

(b)(4) final report additional information including x-rays, operative notes, patient medical history, what the patient was doing at the time of the dislocation, whether the patient followed correct post-op protocol and an update on the patient post revision was requested in order to progress with the investigation of this event, however, not all could be provided and thus the scope of the investigation was limited.It was confirmed that the surgeon revised the ceramic head, removed one bone screw and re-positioned the cup.The surgeon stated that the liner was in a good condition so he re-implanted it.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, it has been concluded that the reported event was due to the cup positioning during primary surgery and 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 represenative or distributor caused or contributed to this event.

Event Description

Trinity revision of the biolox delta ceramic head and a cancellous bone screw on the same day as primary surgery due to dislocation.The reporter stated that the dislocation was due to the positioning of the cup at primary.Please note: the ceramic liner associated with this report is not cleared for sale or distribution within the usa and this event occurred outside of the usa.

• 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: 14631632
• MDR Text Key: 294839767
• Report Number: 9614209-2022-00043
• 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: 08/02/2022

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: 321.03.350
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 473869
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/01/2022
• Initial Date FDA Received: 06/08/2022
• Supplement Dates Manufacturer Received: 06/01/2022
• Supplement Dates FDA Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2021
• 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: 104.3605, 481337; BIOLOX DELTA CERAMIC HEAD: 104.3605, 481337; BIOLOX DELTA CERAMIC LINER: 321.03.436, 471384; BIOLOX DELTA CERAMIC LINER: 321.03.436, 471384; METAFIX COLLARED STEM: 579.2103, 477315; METAFIX COLLARED STEM: 579.2103, 477315; TRINITY SCREW: 321.020, 396422; TRINITY SCREW: 321.020, 396422; TRINITY SCREW: 321.040, 449748; TRINITY SCREW: 321.040, 449748
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 42 YR
• Patient Sex: Female