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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORIN MEDICAL TRINITY ACETABULAR HIP SYSTEM

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CORIN MEDICAL TRINITY ACETABULAR HIP SYSTEM Back to Search Results
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.

 
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Brand NameTRINITY
Type of DeviceACETABULAR 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 Key11568311
MDR Text Key242214988
Report Number9614209-2021-00036
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK093472
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
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 Received03/25/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number321.0.3.352
Device Catalogue NumberNOT APPLICABLE
Device LOT Number392703
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/15/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/27/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/25/2021 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
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