MAUDE Adverse Event Report: CORIN MEDICAL TAPERFIT CEMENTED HIP SYSTEM; HEAD PUSHER

Model Number 340.400

Device Problems Mechanical Jam (2983); Positioning Problem (3009); Insufficient Information (3190)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/07/2021

Event Type  Injury  

Manufacturer Narrative

Per (b)(4) initial report.Additional information, including the appropriate device details and an update on the patient post-op 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.Upon receipt of the device details the relevant device manufacturing records shall 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

During implantation of a trinity dual mobility system, the surgeon was having difficulty relocating the trial head / insert construct because it was too mobile.This led to the head pusher falling down in between the gt and head / neck junction getting jammed, surgery was delayed approximately 40-60 minutes whilst the head pusher was retrieved.

Manufacturer Narrative

Per (b)(4) final report: additional information, including the appropriate device details and an update on the patient post-op has been requested in order to progress with the investigation of this event.However, no more informatiom was provided and the devices were not available for return and review.A trending was performed and it was found that this was the 3rd feedback related to excessive mobility of the trials, but the 1st event with a patient impact.Based on the above, no further investigation can be conducted, and the root cause of the reported issue could not be determined.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 constitue an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.

Event Description

During implantation of a trinity dual mobility system, the surgeon was having difficulty relocating the trial head / insert construct because it was too mobile.This led to the head pusher falling down in between the gt and head / neck junction getting jammed.Surgery was delayed approximately 40-60 minutes whilst the head pusher was retrieved.

• Brand Name: TAPERFIT CEMENTED HIP SYSTEM
• Type of Device: HEAD PUSHER
• Manufacturer (Section D): CORIN MEDICAL; the corinium center; cirencester, GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN MEDICAL; the corinium center; cirencester, GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: marie-anne euzen ; the corinium center; cirencester, GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 11875288
• MDR Text Key: 252655178
• Report Number: 9614209-2021-00067
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K082525
• 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: 01/12/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 340.400
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/11/2021
• Initial Date FDA Received: 05/25/2021
• Supplement Dates Manufacturer Received: 05/11/2021
• Supplement Dates FDA Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: TRINITY DM INSERT TRIAL: PART DETAILS TBC; TRINITY DM LINER TRIAL: PART 9210340 LOT NOT PROV; TRINITY DM LINER TRIAL: PART DETAILS TBC; TRINITY DM TRIAL HEAD: PART DETAILS TBC; TRINITY DM TRIAL HEAD: PART E922.128 LOT NOT PROV
• Patient Outcome(s): Other