Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORIN MEDICAL TRINITY DUAL MOBILITY; ACETABULAR HIP SYSTEM WITH ECIMA LINERS,
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CORIN MEDICAL TRINITY DUAL MOBILITY; ACETABULAR HIP SYSTEM WITH ECIMA LINERS, Back to Search Results
Model Number 325.04.042
Device Problems Loose or Intermittent Connection (1371); Unstable (1667); Device Dislodged or Dislocated (2923)
Patient Problems Joint Dislocation (2374); No Known Impact Or Consequence To Patient (2692); Joint Laxity (4526)
Event Date 07/09/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4) initial report.Additional information, including post primary and pre revision x-rays, operative notes, patient medical history and an update on the patient following the revision has been requested, and if received, will be provided in a supplemental report upon completion of the investigation.It has been confirmed that the explants will be returned for examination.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.
 
Event Description
Trinity dual mobility / taperfit revision of the ecima insert, head and stem after approximately 1 year and 2 months due to dislocation and stem loosening.
 
Event Description
Trinity dual mobility / taperfit revision of the ecima insert, head and stem after approximately 2 months due to dislocation and stem loosening.
 
Manufacturer Narrative
Per -3049 final report.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.The finished parts associated with these records conformed to dimensional and material specifications at the time of manufacture.The provided xrays were reviewed which enabled to confirm the dislocation.The explanted devices were returned to corin and examination of these devices could not identify any obvious failure modes or abnormal device characteristics, except for the ecima insert which was probably misshaped during the dislocation.The rootcause was not established.It was also reported that patient lifted his leg onto the bath tub and leaned over to cut his toenails.Dislocation occurred as he moved into this flexed position.No further investigation for this event is possible at this time as no devices and insufficient information were provided.If additional relevant information becomes available to indicate further evaluation is warranted, this record will be reopened.Thus, this case is now considered closed.Please note: the duration of implantation of the devices (section b5) was corrected compared to the initial report.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 distrubutor caused or contributed to this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TRINITY DUAL MOBILITY
Type of Device
ACETABULAR HIP SYSTEM WITH ECIMA LINERS,
Manufacturer (Section D)
CORIN MEDICAL
the corinium center
cirencester, gl7 1yj GL7 1 YJ
UK  GL7 1YJ
MDR Report Key10307971
MDR Text Key199900487
Report Number9614209-2020-00058
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
PMA/PMN Number
K107359
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 03/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number325.04.042
Device Catalogue NumberNOT APPLICABLE
Device Lot Number446736
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/13/2020
Date Manufacturer Received07/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CEMENT RESTRICTOR, PN: 588.0001, LC: 447791; CEMENT RESTRICTOR, PN: 588.0001, LC: 447791; TAPERFIT STEM, PN: 588.5000, LC: 387414; TAPERFIT STEM, PN: 588.5000, LC: 387414; TRINITY CUP, PN: 321.04.356, LC: 434485; TRINITY CUP, PN: 321.04.356, LC: 434485; TRINITY DM COCR LINER, PN: 321.04.540, LC: 443519; TRINITY DM COCR LINER, PN: 321.04.540, LC: 443519; TRINITY DM COCR MOD HEAD, PN: E321.228, LC: 429348; TRINITY DM COCR MOD HEAD, PN: E321.228, LC: 429348; CEMENT RESTRICTOR, PN: 588.0001, LC: 447791; TAPERFIT STEM, PN: 588.5000, LC: 387414; TRINITY CUP, PN: 321.04.356, LC: 434485; TRINITY DM COCR LINER, PN: 321.04.540, LC: 443519; TRINITY DM COCR MOD HEAD, PN: E321.228, LC: 429348
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age91 YR
-
-