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

Catalog Number	508-01-436
Medical Device Problem Codes	Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Complaint - due to an expired implant was implanted into a patient.
Additional 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
• Common Device Name: 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
• Report Number: 1644408-2024-00506
• Device Sequence Number: 12598548
• Product Code: PHX
• UDI-Device Identifier: 00888912144292
• UDI-Public: 00888912144292
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K051075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 01/10/2024
• Device Catalogue Number: 508-01-436
• Device Lot Number: 923F1926
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 04/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/07/2018
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown