MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC EVOLVE STEM 7.5MM +2; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Model Number	496S275
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was undergoing a radial head replacement for a fractured radial head.The physician trialed a 7.5 plus 2 stem and when they opened the actual it was much bigger size than a 7.5.They noticed this when they tried to use the impactor to impact the stem onto the head and the impactor wouldn't fit over the stem.They checked the box, stickers in the box, and the actual part number on the implant to verify it was in fact the 7.5 stem and all of these checked out.Then they laid the radial head stem next to the trial 7.5 stem and the actual implant was noticeably bigger than the trial.To resolve this issue they ended up using a standard 7.5 stem and added 2 to the head.The procedure was completed with an adequate fixation.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since a review of the dhr did find a deviation indicating a potential mix-up could have occurred during production.It was also determined that two other complaints with a similar allegation was received.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 previous non-conformance has been initiated and necessary actions have been addressed in that record.H3 other text : device disposition unknown.
Event or Problem Description
It was reported that the patient was undergoing a radial head replacement for a fractured radial head.The physician trialed a 7.5 plus 2 stem and when they opened the actual it was much bigger size than a 7.5.They noticed this when they tried to use the impactor to impact the stem onto the head and the impactor wouldn't fit over the stem.They checked the box, stickers in the box, and the actual part number on the implant to verify it was in fact the 7.5 stem and all of these checked out.Then they laid the radial head stem next to the trial 7.5 stem and the actual implant was noticeably bigger than the trial.To resolve this issue they ended up using a standard 7.5 stem and added 2 to the head.The procedure was completed with an adequate fixation.

• Brand Name: EVOLVE STEM 7.5MM +2
• Common Device Name: 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 Key: 15805484
• Report Number: 3010667733-2022-00385
• Device Sequence Number: 20183747
• Product Code: KWI
• UDI-Device Identifier: 00840420185877
• UDI-Public: 00840420185877
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K060731
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2023

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
• Operator of Device: Health Professional
• Device Model Number: 496S275
• Device Catalogue Number: 496S275
• Device Lot Number: 1704691
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2022
• Supplement Date Received by Manufacturer: 12/21/2022
• Initial Report FDA Received Date: 11/16/2022
• Supplement Report FDA Received Date: 01/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Sex: Male