MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EMPOWR/DJO SURGICAL; ALTIVATE ANATOMIC, ALL-POLY PEGGED GLENOID, SIZE 50, E-PLUS

Catalog Number	521-07-250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	07/12/2024
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 patient was complaining of pain.
Additional Manufacturer Narrative
See d4 expiration date, d10, e1 last name, h4 and h11 complaint has been evaluated and is similar to: 1644408-2023-00473; 521-07-254, s807 - pain.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: EMPOWR/DJO SURGICAL
• Common Device Name: ALTIVATE ANATOMIC, ALL-POLY PEGGED GLENOID, SIZE 50, E-PLUS
• 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: 19924766
• Report Number: 1644408-2024-01197
• Device Sequence Number: 19544701
• Product Code: PAO
• UDI-Device Identifier: 00190446178385
• UDI-Public: 00190446178385
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K162024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 10/10/2024

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: 521-07-250
• Device Lot Number: 893U1278
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2022
• 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: 520-08-021 LOT: 1924A1277; 520-50-218 LOT: 949U1222
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR
• Patient Sex: Male