MAUDE Adverse Event Report: ENCORE MEDICAL L.P RSP HUM SOCKET INSERT, 36MM +4MM, SEMI; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number 508-01-436

Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2024

Event Type  Injury  

Event Description

Complaint - due to an expired implant was implanted into a patient.

Manufacturer Narrative

The agent reported that (an expired implant was implanted into a patient in the (b)(6)hospital today.) this event occurred during surgery, near the patient.Significant adverse event was reported by the surgeon.The surgery was completed as intended, with no delay.The implant was inspected prior to use and was deemed acceptable for use based on its appearance.The agent was present during surgery and was able to source a suitable replacement device.Rma examination: the reported expired device has been implanted; agencies are required to verify information on the packaging prior to use.No further evaluation can be made for this event.This customer complaint will be closed.Review of the instrument's device history record (dhr) revealed the instrument, when released for use, met design and manufacturing requirements.There were no ncmrs associated with the production of this instrument.Complaint database review showed nineteen previous complaints but there were no indications that this instrument has a design or material deficiency.S206- sterility expired, 19 the root cause of this complaint is likely due to the surgeon and/or the rep not identifying the expiration date of the device and implanted an expired device.

• Brand Name: RSP HUM SOCKET INSERT, 36MM +4MM, SEMI
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 19103054
• MDR Text Key: 340106087
• Report Number: 1644408-2024-00506
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912144292
• UDI-Public: 00888912144292
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K051075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2024
• Device Catalogue Number: 508-01-436
• Device Lot Number: 923F1926
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/07/2018
• 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
• Patient Outcome(s): Other