MAUDE Adverse Event Report: ENCORE MEDICAL L.P. ALTIVATE REVERSE, HUMERAL STEM, SMALL SHELL, SZ 10X108MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	533-10-108
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Dislocation (2374); Limb Fracture (4518); Joint Laxity (4526)
Date of Event	04/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to dislocation, fracture and loosening.
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
See d4 expiration date, h4 and h11.Complaint has been evaluated and is similar to:1644408-2018-01191, 533-10-108, s810 - device loosening, s803 - dislocation, 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 10X108MM
• 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: 19244728
• Report Number: 1644408-2024-00601
• Device Sequence Number: 12504681
• Product Code: KWS
• UDI-Device Identifier: 00190446259152
• UDI-Public: 00190446259152
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K172351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 07/15/2024

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: 533-10-108
• Device Lot Number: 929W1897
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 05/04/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2023
• 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: 508-32-101 LOT: 862C4320; 509-02-432 LOT: 953W1383
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 71 YR
• Patient Sex: Male