MAUDE Adverse Event Report: ENCORE MEDICAL L.P ALTIVATE ANATOMIC, OFFSET HUMERAL HEAD, 54X20; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED

Catalog Number	520-54-320
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to dislocation.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to previous report number 1644408-2021-00892; 520-50-318, 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 ANATOMIC, OFFSET HUMERAL HEAD, 54X20
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, 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 ; MX 78758
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 19455657
• Report Number: 1644408-2024-00822
• Device Sequence Number: 15430696
• Product Code: PAO
• UDI-Device Identifier: 00190446176275
• UDI-Public: 00190446176275
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: K162024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• 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): 06/03/2024

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 Expiration Date: 04/20/2023
• Device Catalogue Number: 520-54-320
• Device Lot Number: 880U1006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2024
• Initial Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2017
• 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: 520-07-000 LOT: 888U1032; 520-16-000 LOT: 854U1011; 521-07-250 LOT: 893U1013
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male