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

Model Number 520-42-216

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

Patient Problem Joint Dislocation (2374)

Event Date 06/13/2023

Event Type  Injury  

Event Description

Revision surgery - due to dislocation.

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

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: 17295083
• MDR Text Key: 318831971
• Report Number: 1644408-2023-00887
• Device Sequence Number: 1
• Product Code: PAO
• UDI-Device Identifier: 00190446176091
• UDI-Public: 00190446176091
• 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,Followup
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 520-42-216
• Device Catalogue Number: 520-42-216
• Device Lot Number: 947U1054
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 888U1476; 520-08-000 LOT: 650U1067; 521-07-238 LOT: 890U1072
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female