MAUDE Adverse Event Report: KYOCERA MEDICAL TECHNOLOGIES, INC. KYOCERA MEDICAL TECHNOLOGIES, INC; TAPERED FEMORAL STEM, STD OFFSET, 10.5MM

Model Number A 400

Device Problem Expiration Date Error (2528)

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

Event Date 01/20/2022

Event Type  malfunction  

Manufacturer Narrative

As reported, an expired hip stem was inadvertently implanted into the patient.There was no reported patient injury/infection.No revision surgery was reported.The expiration date is located on multiple layers of the packaging.This event is confirmed as a user related error with no malfunction of the device.Review of manufacturing records confirms product was manufactured to specification and there is no indication of a product quality issue with respect to design, manufacturing, or labeling.To date, this is the only reported complaint from this manufacturing lot released for distribution in november 2016.Since the expired product remains implanted in the patient and will not be revised/returned, the packaging of 10 stems that expired on the same date as the subject stem was tested.The results of these packaging tests showed that the packaging still retained sufficient package seal strength and package seal integrity post expiration, implying that the reported stem likely also retained sufficient seal strength and seal integrity post expiration at time of implantation.This product complaint investigation will be included in an ongoing internal capa related to expired or expiring inventory.Should additional information be provided by the healthcare provider, a supplemental mdr will be submitted.

Event Description

Expired implant was used in surgery on (b)(6) 2022.Implant expired on 10/13/2021.Implantation was an oversight from both the surgical rep.And the nurse in surgery who call out the items being implanted.

• Brand Name: KYOCERA MEDICAL TECHNOLOGIES, INC
• Type of Device: TAPERED FEMORAL STEM, STD OFFSET, 10.5MM
• Manufacturer (Section D): KYOCERA MEDICAL TECHNOLOGIES, INC.; 1200 california st.; suite 210; redlands CA 92374
• Manufacturer (Section G): KYOCERA MEDICAL TECHNOLOGIES, INC.; 1200 california st.; suite 210; redlands CA 92374
• Manufacturer Contact: anthony debenedictis ; 1200 california st.; suite 210; redlands, CA 92374 ; 9095572160
• MDR Report Key: 13565125
• MDR Text Key: 288608674
• Report Number: 3015398319-2022-00001
• Device Sequence Number: 1
• Product Code: OQI
• UDI-Device Identifier: 00841523102549
• UDI-Public: 00841523102549
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112897
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/13/2021
• Device Model Number: A 400
• Device Catalogue Number: 1401-322-105
• Device Lot Number: 2872-2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2016
• 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