MAUDE Adverse Event Report: ENCORE MEDICAL L.P GLENOID, HEAD W/RETAINING SCREW, RSP, 40MM/-4MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	508-40-103
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Revision surgery - due to infection.
Additional Manufacturer Narrative
See d4 expiration date and h4.The reason for this revision surgery, the agent reported "(infection.Dr.Used osteoremedies implants for revision)." the actual length of in-vivo for the item(s) listed is unknown as the original surgery date was not provided or could be established.Note: the previous dticket/invoice was not provided.A search of djo records, with the limited information, produced no results.Therefore, the reported item could not be verified.This evaluation is limited in scope as limited information was provided to djo surgical - austin for examination.If information regarding cultures identified in the infection, the severity of the infection or any other relevant information is submitted at a future date, this investigation will be re-evaluated.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.There were no findings during this evaluation that indicate that the reported device(s) was the source or had a direct connection with the patient's infection.A review of the device history record(s) show that the reported component(s) used in the previous surgery, when released for use, met design and manufacturing requirements.There were no nonconforming material reports associated with the product(s) that may have contributed to the reported event.The device(s) was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of the previous surgery.Customer complaint history of the reported device(s) showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a revision surgery due to an infection.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the infection or inhibited the patient's immune system.There are multiple factors that may contribute to an infection that are outside of the control of djo surgical.
Additional Manufacturer Narrative
Note: the previous dticket/invoice was not provided.Attached dt to investigation is the primary surgery confirmed by the agent.There was a revision surgery after the primary surgery and before the current revision surgery.A search of djo records for the 1st revision surgery, with the limited information, produced no results.Therefore, the reported item could not be verified.

• Brand Name: GLENOID, HEAD W/RETAINING SCREW, RSP, 40MM/-4MM
• 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: 16686460
• Report Number: 1644408-2023-00425
• Device Sequence Number: 5772686
• Product Code: PHX
• UDI-Device Identifier: 00888912144513
• UDI-Public: 00888912144513
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/23/2023

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: 08/25/2026
• Device Model Number: 508-40-103
• Device Catalogue Number: 508-40-103
• Device Lot Number: 876C1186A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2023
• Supplement Date Received by Manufacturer: 05/30/2023; 06/01/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 05/31/2023; 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2020
• 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: Required Intervention; Other
• Patient Age: 67 YR
• Patient Sex: Unknown