MAUDE Adverse Event Report: STRYKER/HOWMEDICA OSTEONICS CORP STRYKER FEMORAL POSTERIOR STABILIZED #7; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number LT 5515-F-701

Device Problems Improper or Incorrect Procedure or Method (2017); Expiration Date Error (2528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2023

Event Type  malfunction  

Event Description

Two stryker reps present for this knee implant case on (b)(6) 2023.One stryker rep brought the implants into or room.Another stryker rep took over from the other rep and determined that one of the implants needed to be exchanged for another one.The stryker rep left the room and then brought in another implant to replace it.The stryker rep then checked all info on the implants then left the room.The surgeon asked for implants to be opened so the circulator checked the implants and noted the year of 2023 and opened them.However the circulator rn did not notice that the month of the expiration date noted on the implant device label was actually (b)(6) so an expiration date of 02/2023 for this implant.The stryker rep came back into the or and noticed that the expiration date was expired for the implant he had brought into the room and told the surgeon right away and asked him to remove the implant so he could give him a new one.At that point in time the femoral posterior stabilized #7 lt 5515-f-701, log610430 had already been implanted and cemented in place in the patient's knee.Physician decision was made to not attempt any type of extraction of the component as the risks to the patient outweighed the benefits.Expired item had been removed to an area outside of the or and then picked up inadvertently by the stryker representative and brought into the or.This area was where the expired stryker implant devices had been set aside for removal from the facility.Information on if sterilization validation testing data is on file as part of the 510k submission that may show data beyond the stated expiration date timeline has been requested by the hospital risk management department from stryker.Response still pending.Reference report #mw5117372.

• Brand Name: STRYKER FEMORAL POSTERIOR STABILIZED #7
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER/HOWMEDICA OSTEONICS CORP; mahwah NJ 07430
• MDR Report Key: 16894638
• MDR Text Key: 314932591
• Report Number: MW5117373
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/04/2023

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
• Device Operator: Health Professional
• Device Model Number: LT 5515-F-701
• Device Catalogue Number: LT 5515-F-701
• Device Lot Number: LOG610430
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White