MAUDE Adverse Event Report: ENCORE MEDICAL L.P. AR, SMALL SOCKET INSERT, 36MM NEUTRAL +4 EPLUS; REVERSE PROSTHESIS SHOULDER SYSTEM

Catalog Number	509-02-436
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - mdr - significant adverse event/required intervention to prevent impairment/damage (revision).
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to: 1644408-2022-01643, 509-02-436, (b)(6) - dissociation, revision surgery; surgical quality complaints.Note: see the attached follow up emails showing no response in regard to the return of the explant.If additional information regarding the reported event is submitted at a future date or if the explant is returned, this investigation will be re-evaluated.

• Brand Name: AR, SMALL SOCKET INSERT, 36MM NEUTRAL +4 EPLUS
• Common Device Name: REVERSE PROSTHESIS SHOULDER SYSTEM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758-5445
• MDR Report Key: 18213158
• Report Number: 1644408-2023-01665
• Device Sequence Number: 12417764
• Product Code: KWS
• UDI-Device Identifier: 00190446257615
• UDI-Public: 00190446257615
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K172351
• 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
• Report Date (Section B): 01/05/2024

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 Catalogue Number: 509-02-436
• Device Lot Number: 957W1106
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 11/27/2023
• Supplement Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2022
• 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: 506-03-114 , LOT 831C2208.; 506-03-118 , LOT 832C1947.; 506-03-130 , LOT 835C1988.; 508-36-101 , LOT 869C3625.; 533-08-000 , LOT 004Y1123.; 533-10-108 , LOT 929W1705.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male