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 No Apparent Adverse Event (3189)

Patient Problem Insufficient Information (4580)

Event Date 10/18/2023

Event Type  Injury  

Event Description

It was reported there was a 25 minute delay in surgery.

Manufacturer Narrative

Complaint has been evaluated and is similar to previous report number 1644408-2021-01414; 520-46-216, s800 - revision surgery, 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: 18136941
• MDR Text Key: 328109078
• Report Number: 1644408-2023-01633
• 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
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 520-42-216
• Device Lot Number: 947U1136
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/18/2023
• 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: 520-08-018 LOT: 1923A1126.
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female