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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 694.0001
Device Problems Nonstandard Device (1420); Device Markings/Labelling Problem (2911)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/10/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).A trifit ts size 2 stem (694.0002) was incorrectly labeled as a trifit ts size 1 stem (694.0001), this was identified during surgery.The surgeon made the decision to implant the size 2 stem as no alternative size 1 stem was available.The lot code marked on the size 2 stem was not provided, however following an investigation 2 potential lot codes were identified as being packed on the same day as the size 1 stem.The location of these devices along with the batch of size 1 stems has been identified and the available devices are being returned to corin uk.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
A trifit ts size 2 stem (694.0002) was incorrectly labeled as a trifit ts size 1 stem (694.0001), this was identified during surgery.The surgeon made the decision to implant the size 2 stem as no alternative size 1 stem was available.
 
Event Description
A trifit ts size 2 stem (694.0002) was incorrectly labeled as a trifit ts size 1 stem (694.0001), this was identified during surgery.The surgeon made the decision to implant the size 2 stem as no alternative size 1 stem was available.
 
Manufacturer Narrative
Per -2273 final report.A trifit ts size 2 stem (694.0002) was incorrectly labeled as a trifit ts size 1 stem (694.0001), this was identified during surgery.The surgeon made the decision to implant the size 2 stem as no alternative size 1 stem was available.The lot code marked on the size 2 stem was not provided, however, following an investigation 2 potential lot codes were identified as being packed on the same day as the size 1 stem.The location of these devices along with the batch of size 1 stems has been identified and the unused stems have been returned to corin uk.The investigation of this event identified that the reported event occurred due to human error whereby the process was incorrectly followed.Since the manufacture of this device, corin has introduced improvements to the process and review activities which would capture any such issues.Therefore this case is now considered closed.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 the event.
 
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Brand Name
TRIFIT TS
Type of Device
HIP STEM
Manufacturer (Section D)
CORIN MEDICAL
the corinium centre
cirencester
gloucestershire, GL7 1 YJ
UK  GL7 1YJ
MDR Report Key8878874
MDR Text Key153843630
Report Number9614209-2019-00074
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
PMA/PMN Number
K121563
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Remedial Action Recall
Type of Report Initial,Followup
Report Date 12/12/2019
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 Date03/01/2024
Device Model Number694.0001
Device Catalogue NumberNOT APPLICABLE
Device Lot Number408076
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/10/2019
Initial Date FDA Received08/09/2019
Supplement Dates Manufacturer Received07/10/2019
Supplement Dates FDA Received12/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
TRIFIT TS STEM - 694.1002, 411523; TRIFIT TS STEM - 694.1002, 411523; TRIFIT TS STEM - 694.1002, 411524; TRIFIT TS STEM - 694.1002, 411524; TRIFIT TS STEM - 694.1002, 411523; TRIFIT TS STEM - 694.1002, 411524
Patient Outcome(s) Hospitalization; Required Intervention;
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