MAUDE Adverse Event Report: ENCORE MEDICAL L.P ALTIVATE REVERSE, HUMERAL STEM, SMALL SHELL, SZ 8X48MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	533-08-048
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	02/15/2024
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 fracture.
Additional Manufacturer Narrative
See d4 expiration date, d10 and h4 complaint has been evaluated and is similar to previous report number 1644408-2020-00715; 533-08-048, s809 - trauma, revision surgery if additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: ALTIVATE REVERSE, HUMERAL STEM, SMALL SHELL, SZ 8X48MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 18882636
• Report Number: 1644408-2024-00298
• Device Sequence Number: 14221669
• Product Code: KWS
• UDI-Device Identifier: 00190446334965
• UDI-Public: 00190446334965
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K190290
• 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): 04/25/2024

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: 533-08-048
• Device Lot Number: 1491A1252
• 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: 03/21/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2023
• 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: 509-02-036 LOT: 955W1267
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female