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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC EVOLVE STEM 7.5MM +2; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
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WRIGHT MEDICAL TECHNOLOGY INC EVOLVE STEM 7.5MM +2; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER Back to Search Results
Model Number 496S275
Device Problem Inaccurate Information (4051)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/19/2022
Event Type  Injury  
Event Description
It was reported that customer opened a 7.5 +2 stem, the box says that, the product even has the correct code stamped on it however the actually stem is larger.Customer didn¿t have the same size, needed to resect more bone from the patient and use a +4 stem.
 
Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
 
Manufacturer Narrative
The reported event could be confirmed, since the returned device was found to have incorrect dimensions.Examination finds the etching on the device to be catalog: 496s275, lot 1704691.Dimensional inspection of the stem found the measurement to be 9.48mm not 7.5mm as indicated by the catalog 496s275 specifications.A review of the dhr did find a deviation indicating a potential mix-up could have occurred during production.Based on investigation, the root cause was attributed to a manufacturing related issue.The failure was caused by an apparent mix-up during quality inspections prior to the laser marking process.A nonconformance was opened to further investigate the issue.
 
Event Description
It was reported that customer opened a 7.5 +2 stem, the box says that, the product even has the correct code stamped on it however the actually stem is larger.Customer didn¿t have the same size, needed to resect more bone from the patient and use a +4 stem.
 
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Brand Name
EVOLVE STEM 7.5MM +2
Type of Device
PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
Manufacturer (Section D)
WRIGHT MEDICAL TECHNOLOGY INC
1023 cherry rd
memphis TN 38117
Manufacturer (Section G)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
arlington TN 38002
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key14680374
MDR Text Key294287577
Report Number3010667733-2022-00206
Device Sequence Number1
Product Code KWI
UDI-Device Identifier00840420185877
UDI-Public00840420185877
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K060731
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 08/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number496S275
Device Catalogue Number496S275
Device Lot Number1704691
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/31/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received07/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/07/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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