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

Model Number 321.03.352

Device Problem Failure to Align (2522)

Patient Problem No Code Available (3191)

Event Date 09/10/2019

Event Type  Injury  

Manufacturer Narrative

Per -2410 combined report.The patient was reported to be an 80 year old female, 85kg with an average activity level.Patient medical history, x-rays, imaging and the explanted devices could not be provided for this event and thus the investigation was very limited.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.It was reported to corin that during primary surgery the cup was implanted with a lack of anteversion and thus it has been concluded that this is most likely the cause of the malalignment and "clunking feelings" experienced by the patient and thus 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.

Event Description

Trinity revision of the cup, liner, head and two screws after approximately 4 years and 4 months due to malalignment of the cup.The patient was reported to be experiencing a "clunkling feeling".Please note: the biolox delta ceramic liner associated with this event 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: franck didier ; the corinium centre; cirencester; gloucestershire, GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 9174508
• MDR Text Key: 168433877
• Report Number: 9614209-2019-00097
• 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
• Report Date: 10/10/2019

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 Expiration Date: 02/17/2020
• Device Model Number: 321.03.352
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 302335
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/12/2019
• Initial Date FDA Received: 10/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2015
• 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
• Patient Outcome(s): Hospitalization; Required Intervention