MAUDE Adverse Event Report: ENCORE MEDICAL L.P. ALTIVATE REVERSE SHOULDER; AR, SMALL SOCKET INSERT, 40MM NEUTRAL +4 EPLUS

Catalog Number	509-02-440
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to previous report number 1644408-2022-01740, 509-02-432, s803 - dislocation, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.
Event or Problem Description
Revision surgery - patient with significant revision reverse total shoulder history had an allograft/prothesis composite reconstruction on the humeral side due to proximal bone loss.However patient was still having a significant number of dislocation events.Intraoperatively the patient was found to have significant retroversion of the well fixed humeral component and the glenoid component was found to be well fixed as well.A 12mm spacer and +4 poly was added the humeral component to hopefully make the patient stable long term.

• Brand Name: ALTIVATE REVERSE SHOULDER
• Common Device Name: AR, SMALL SOCKET INSERT, 40MM NEUTRAL +4 EPLUS
• 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: 18213146
• Report Number: 1644408-2023-01708
• Device Sequence Number: 20668902
• Product Code: KWS
• UDI-Device Identifier: 00190446257653
• UDI-Public: (01)00190446257653
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• 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): 11/27/2023

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 Catalogue Number: 509-02-440
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Age: 74 YR
• Patient Sex: Male