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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORIN MEDICAL TRINITY DUAL MOBILITY ACETABULAR HIP SYSTEM

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CORIN MEDICAL TRINITY DUAL MOBILITY ACETABULAR HIP SYSTEM Back to Search Results
Model Number 325.03.040
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
Patient Problem Unspecified Infection (1930)
Event Date 04/07/2022
Event Type  Injury  
Event Description
Trinity dual mobility revision of the ecima insert and trinity biolox delta ceramic head after 2 weeks and 2 days due to infection. The patient had a washout and a head and liner change.
 
Manufacturer Narrative
Per (b)(4) initial report: it was reported that the patient had experienced a fall post primary surgery which resulted in the surgical wound opening up and a wound dehiscene to occur. The patient did not tell anyone about the fall / wound for four days and subsequently got an infection. Additional information including x-rays, patient medical history and medical / operative notes has been requested in order to progress with the investigation of this event, and if received, will be provided in a supplemental report upon completion of the investigation. The appropriate device details have been provided and the relevant device manufacturing records will be identified and reviewed. 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.
 
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Brand NameTRINITY DUAL MOBILITY
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
marie-anne euzen
the corinium centre
cirencester, gloucestershire GL7 1-YJ
UK   GL7 1YJ
MDR Report Key14103180
MDR Text Key289201993
Report Number9614209-2022-00026
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K170359
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number325.03.040
Device Catalogue NumberNOT APPLICABLE
Device Lot Number494114
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/29/2021
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: 04/13/2022 Patient Sequence Number: 1
Treatment
BIOLOX DELTA CERAMIC HEAD: 104.2800, 490288; BIOLOX DELTA CERAMIC HEAD: 104.2800, 490288; TRINITY CUP: 321.03.352, 478039; TRINITY CUP: 321.03.352, 478039; TRINITY DM COCR LINER: 321.03.536, 486451; TRINITY DM COCR LINER: 321.03.536, 486451
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