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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORIN MEDICAL TRIFIT TS HIP STEM

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CORIN MEDICAL TRIFIT TS HIP STEM Back to Search Results
Model Number 694.0003
Device Problem Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2020
Event Type  Injury  
Manufacturer Narrative
Per -(b)(4) combined report. Additional information, including post primary and pre revision x-rays, operative notes, patient details and an update on the patient post-op was requested. It was confirmed that the patient was doing well post-op and that the subsidence and subsequent revision was secondary to poor patient bone quality. None of the other information could be provided and the explanted devices could not be returned for examination. 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. Based on the available information, no further investigation can be conducted and the root cause of the event could not be determined, however, as stated by the reporter is may be due to the quality of the patient's bone. 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
Trfit ts / trinity revision of the ceramic head, stem and uhmwpe liner after approximatively 4 years and 3 months due to stem subsidence.
 
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Brand NameTRIFIT TS
Type of DeviceHIP STEM
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
marie-anne euzen
the corinium centre
cirencester, gloucestershire GL7 1-YJ
UK   GL7 1YJ
MDR Report Key11841283
MDR Text Key251150244
Report Number9614209-2021-00065
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K121563
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 05/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/04/2021
Device Model Number694.0003
Device Catalogue NumberNOT APPLICABLE
Device Lot Number333529
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/12/2016
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: 05/18/2021 Patient Sequence Number: 1
Treatment
BIOLOX DELTA CERAMIC HEAD:104.3200, 335502; TRINITY CUP: 321.02.348, 332653; TRINITY UHMWPE LINER: 321.02.932, 332388
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