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

Model Number 496S275

Device Problem Inaccurate Information (4051)

Patient Problem Insufficient Information (4580)

Event Date 03/15/2022

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.

Event Description

It was reported that the surgeon opened a evolve 7.5 +2 stem and inside the package was what looked like a 9.5 +2 stem.This delayed the process of implantation.Luckily we were able to go +2 with the head and standard stem to achieve the same tension.Would have been a different case if he used standard for both seeing as we only had one of each.

Event Description

It was reported that the surgeon opened a evolve 7.5 +2 stem and inside the package was what looked like a 9.5 +2 stem.This delayed the process of implantation.Luckily we were able to go +2 with the head and standard stem to achieve the same tension.Would have been a different case if he used standard for both seeing as we only had one of each.

Manufacturer Narrative

Correction: d4 expiration date.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 a second complaint 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 nonconformance was opened to further investigate the issue.

• 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 Key: 14063798
• MDR Text Key: 289985032
• Report Number: 3010667733-2022-00154
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 00840420185877
• UDI-Public: 00840420185877
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060731
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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?: No
• Date Manufacturer Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1