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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 NOT PROVIDED
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Pain (1994); Swelling (2091)
Event Date 05/24/2018
Event Type  Injury  
Manufacturer Narrative
Per -3075 initial report.It was reported that the patient has been experiencing reddening, swelling and pain in the hip joint.It has been reported that there has been no revision or bacterial infection present.The device material composition has been provided to the surgeon.Additional information including device details and an update on the patient has been requested, and if received, will be provided in a supplemental report upon completion of the investigation.Upon receipt of the appropriate device details, the device manufacturing records will be identified and reviewed.Please note: this report is filed with the fda due to an 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
Corin received notification of a patient who is reported to have reddening, swelling and pain in the hip joint following implantation of an alpha-lock cup, alpha-fit stem, trinity uhmwpe liner and biolox delta ceramic head.Please note: the associated alpha-lock cup and alpha-fit stem are not cleared for sale or distribution in the usa and this event occurred outside of the usa.
 
Event Description
Corin received notification of a patient who is reported to have reddening, swelling and pain in the hip joint following implantation of an alpha-lock cup, alpha-fit stem, trinity uhmwpe liner and biolox delta ceramic head.Please note: the associated alpha-lock cup and alpha-fit stem are not cleared for sale or distribution in the usa and this event occurred outside of the usa.
 
Manufacturer Narrative
Per -3075 final report.It was reported that the patient has been experiencing reddening, swelling and pain in the hip joint.It has been reported that there has been no revision or bacterial infection present.The device material compostion has been provided to the surgeon.Additional information including device details and an update on the patient was requested, however, this information was not provided and thus an investigation cannot be conducted.The appropriate device details have not been provided and thus the relevant device manufacturing records cannot be identfied or reviewed.Based on the available information, no investigation can be conducted and the root cause of the event was not determined.Therefore, 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 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.
 
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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
MDR Report Key10430490
MDR Text Key203645651
Report Number9614209-2020-00066
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
PMA/PMN Number
K093472
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 02/04/2021
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 Model NumberNOT PROVIDED
Device Catalogue NumberNOT APPLICABLE
Device Lot NumberNOT PROVIDED
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/24/2020
Initial Date FDA Received08/20/2020
Supplement Dates Manufacturer Received07/24/2020
Supplement Dates FDA Received02/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ALPHA-FIT STEM - DEVICE DETAILS UNKNOWN; ALPHA-FIT STEM - DEVICE DETAILS UNKNOWN; ALPHA-LOCK CUP - DEVICE DETAILS UNKNOWN; ALPHA-LOCK CUP - DEVICE DETAILS UNKNOWN; BIOLOX DELTA CERAMIC HEAD - DEVICE DETAILS UNKNOWN; BIOLOX DELTA CERAMIC HEAD - DEVICE DETAILS UNKNOWN; ALPHA-FIT STEM - DEVICE DETAILS UNKNOWN; ALPHA-LOCK CUP - DEVICE DETAILS UNKNOWN; BIOLOX DELTA CERAMIC HEAD - DEVICE DETAILS UNKNOWN
Patient Outcome(s) Other;
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