MAUDE Adverse Event Report: ENCORE MEDICAL L.P RSP HUM SOCKET INSERT, 40MM +4MM, SEMI; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	510-06-220
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/14/2023
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
The reason for this revision surgery, the agent reported "(bilateral right shoulder prosthesis replacement due to infection.Implantation of 220mm rsp 6mm long stem with missing proximal bonestock in 2016.In 2022 fatigue fracture of distal prosthetic stem.Removal of rsp stem, implantation of lima prox humeral stem prosthesis)." 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 and revision dticket/invoices were not provided to verify the explants and implanted items.This evaluation is limited in scope as limited information was provided to djo surgical - austin.The item(s) associated with this investigation were returned.There was no information regarding cultures identified in the infection, or the severity of the infection.If any 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.

• Brand Name: RSP HUM SOCKET INSERT, 40MM +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: 16686459
• Report Number: 1644408-2023-00408
• Device Sequence Number: 17585645
• Product Code: PHX
• UDI-Device Identifier: 00888912144308
• UDI-Public: 00888912144308
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K100741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 06/23/2023
• 2 Devices were Involved in the Event: 1 2

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: 05/28/2018
• Device Model Number: 510-06-220
• Device Catalogue Number: 508-01-440
• Device Lot Number: 924F1016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2013
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 508-40-101 LOT: 875C1056.; 510-06-220 LOT: 145N1004.; 510-08-000 LOT: 142G1149.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female