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

Model Number 321.04.356

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 09/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information, including post primary and pre revision x-rays, operative notes, patient age and activity level, a detailed patient outcome and the explanted devices has been requested in order to progress with this investigation, and if received, will be provided in a supplemental report upon completion of this 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.

Event Description

Trinity revision after approximately 2 months due to lack of cup in-growth.

Manufacturer Narrative

(b)(4) final report.Additional information, including post primary and pre revision x-rays, operative notes, patient age and activity level, a detailed patient outcome and the explanted devices was requested in order to progress with this investigation.However, none were available and thus there was only very limited information available for the investigation.The explants were discarded by the hospital following the revision and thus could not be examined.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.From the information provided in the report to corin, it appears that despite the addition of three screws, the cup did not achieve primary fixation through adequate press-fit with the acetabulum leading to loosening/movement of the cup.The surgeon has also commented that he believes the movement/loosening of the cup could be due to a fracture of the patient's pelvis which healed.Based on the information available, no further investigation can be conducted and thus corin now consider this case 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.

Event Description

Trinity revision after approximately 2 months due to lack of cup in-growth.

• 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: franck didier ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ ; 1285659866
• MDR Report Key: 7078842
• MDR Text Key: 93592890
• Report Number: 9614209-2017-00076
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K111481
• 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: 06/18/2018

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: 321.04.356
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 272239
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/25/2017
• Initial Date FDA Received: 12/04/2017
• Supplement Dates Manufacturer Received: 09/25/2017
• Supplement Dates FDA Received: 06/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2014
• 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: TRINITY ECIMA LINER 322.04.636, 322.04.636; TRINITY SCREW - 321.030, 328941; TRINITY SCREW - 321.035, 281028; TRINITY SCREW - 321.035, 301229
• Patient Outcome(s): Hospitalization; Required Intervention