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 MOBILIT; HOLDER / IMPACTOR
  • 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 MOBILIT; HOLDER / IMPACTOR Back to Search Results
Model Number MDM002
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/09/2022
Event Type  malfunction  
Event Description
Mobilit holder/impactor handle would not disengage from the cup following impaction.The cup was implanted and the impaction handle was loosened, but it could not be separated from the cup.It was stuck and could not be removed, so the cup had to be explanted.Trinity cup with modular dual mobility were use to complete the surgery.
 
Manufacturer Narrative
(b)(4) initial report.Additional information, including clarification on the cup holder attachment used and clarification of the event were requested and received.The return of the reported devices was requested.The appropriate device details have been provided and the relevant device manufacturing records will be identified and reviewed.The submission of this report does not constitute that the device reporting entity, entity's representative or distributor caused or contributed to this event.
 
Manufacturer Narrative
Per (b)(4) final report.The reported devices were returned to corin for examination, which allowed us to confirm the failure mode.The relevant device manufacturing records were identified and reviewed.The impactor was supplied in august 2021, and the cup holder attachment was supplied in march 2022.Both devices conformed to material and dimensional specifications at the time of manufacture.Based on the investigation, the condition of the first couple of threads suggest that it never engaged with the female thread correctly.When the surgeon impacted the cup the first time, this probably damaged the threads and caused the cup holder attachment stayed expanded.In this hypothesis, the root cause is probably due to a misuse.Based on this, corin now consider this case closed.A monitoring will be done on this failure mode.The submission of this report does not constitute that the device reporting entity, entity's representative or distributor caused or contributed to this event.
 
Event Description
Mobilit holder/impactor handle would not disengage from the cup following impaction.The cup was implanted and the impaction handle was loosened, but it could not be separated from the cup.It was stuck and could not be removed, so the cup had to be explanted.Trinity cup with modular dual mobility were use to complete the surgery.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MOBILIT
Type of Device
HOLDER / IMPACTOR
Manufacturer (Section D)
CORIN MEDICAL
the corinium centre
cirencester, gloucestershire GL71Y J
UK  GL71YJ
Manufacturer (Section G)
CORIN MEDICAL
the corinium centre
cirencester, gloucestershire GL7 1 YJ
UK   GL7 1YJ
Manufacturer Contact
dardan uka
the corinium centre
cirencester, gloucestershire GL7 1-YJ
UK   GL7 1YJ
MDR Report Key14432989
MDR Text Key292391648
Report Number9614209-2022-00028
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191831
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMDM002
Device Catalogue NumberNOT APPLICABLE
Device Lot Number101911-04
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/09/2022
Initial Date FDA Received05/18/2022
Supplement Dates Manufacturer Received05/09/2022
Supplement Dates FDA Received07/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/04/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
MOBILIT CUP HOLDER ATTACHMENT: MDM050A,101910-05; MOBILIT CUP HOLDER ATTACHMENT: MDM050A,101910-05
-
-