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

Model Number 321.0.3.352

Device Problem Noise, Audible (3273)

Patient Problem Joint Laxity (4526)

Event Date 03/15/2021

Event Type  Injury  

Manufacturer Narrative

Per -(b)(4).Additional information including x-rays, operative notes, patient details, whether the patient experienced any trauma and an update on the patient post revision was requested, however, not all could be provided.It was reported that the patient had an unknown activity level and had not experienced any trauma but had been having instability and clunking quite soon after primary surgery.The explanted devices could not be provided for examination.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.All parts associated with these records conformed to material and dimensional specification at the time of manufacture.Based on the available information, no further investigation can be conducted and the root cause of the reported instability and clunking could not be determined, however, it was stated in the event report that the new cup was implanted with less version and thus it is a possibility that positioning of the acetabular cup at primary surgery may have conrtibuted to this event.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.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 cup, ecima liner and ceramic head after approximately 2 years and 5 months due to the patient experiencing instability and clunking.

• 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: sean moule ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 11568311
• MDR Text Key: 242214988
• Report Number: 9614209-2021-00036
• 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: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2023
• Device Model Number: 321.0.3.352
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 392703
• Date Manufacturer Received: 03/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2018
• 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 - 104.3600, 403139; METAFIX COLLARED STEM - 579.0104, 391927; TRINITY ECIMA LINER - 322.03.636, 399327
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR