MAUDE Adverse Event Report: ENCORE MEDICAL L.P ALTIVATE ANATOMIC, NEUTRAL HUMERAL HEAD, 42X16; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED

Catalog Number 520-42-216

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Dislocation (2374)

Event Date 12/08/2023

Event Type  Injury  

Event Description

Revision surgery - due to dislocation.

Manufacturer Narrative

Complaint has been evaluated and is similar to previous report number 1644408-2020-00665; 520-42-216, 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, NEUTRAL HUMERAL HEAD, 42X16
• Type of Device: 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
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 18451664
• MDR Text Key: 332180237
• Report Number: 1644408-2023-01960
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2023
• Device Catalogue Number: 520-42-216
• Device Lot Number: 947U1017
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 520-07-000 LOT: 888U1101; 520-10-000 LOT: 851U1067; 521-07-242 LOT: 891U1016
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Female