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

Model Number 321.04.354

Device Problems Break (1069); Mechanical Jam (2983); No Apparent Adverse Event (3189); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/11/2022

Event Type  malfunction  

Manufacturer Narrative

Additional information including the device part numbers and lot codes, photograps of the reported devices, operative notes, whether the cup was fully threaded prior to impaction, whether there was any thread damage prior to use, an update on the patient post-op and whether the devices are available for examination has been requested in order to progress with the investigation of this event, and if receieved, will be provided in a supplemental report upon completion of the investigation.Upon receipt of the appropriate device details, the relevant device manufacturing records will be identified and reviewed.Please note: this report is filed with the fda due to an 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

The offset cup impactor threads became jammed and then stuck in definitive cup.The surgeon was then unable to remove thread piece from cup resulting in opening another cup and broken offset impactor.This event caused a surgical delay 20 mins.

Event Description

A trinity cup became stuck with a non-corin impactor handle intra-operatively.The surgeon was then unable to remove thread piece from cup resulting in opening another cup and broken offset impactor.This event caused a surgical delay 20 mins.

Manufacturer Narrative

Per -4882 final report.Additional information including operative notes, if the device can be returned, photos of the failure and thread damage prior to use was requested however, this information could not be provided.The appropriate device details were provided and the relevant device manufacturing and sterilisation records for the tinity cup have been identified and reviewed.This part was manufactured to the correct specifications at the time of manufacture.Based on the available information, no further investigation can be conducted and the root cause could not be determined.Therefore, 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 representative or distributor caused or contributed to this event.

• Brand Name: TRINITY
• Type of Device: ACETABULAR HIP SYSTEM
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester; 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: 15075457
• MDR Text Key: 302014127
• Report Number: 9614209-2022-00059
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K122305
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 321.04.354
• Device Catalogue Number: N/A
• Device Lot Number: 494683
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 07/21/2022
• Supplement Dates Manufacturer Received: 07/12/2022
• Supplement Dates FDA Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TRINITY CUP: 321.04.354, LOT NOT PROVIDED