MAUDE Adverse Event Report: ENCORE MEDICAL L.P ALTIVATE ANATOMIC CS, HUMERAL STEM AND NECK KIT, SIZE 3; PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM

Catalog Number 520-08-024

Device Problem No Apparent Adverse Event (3189)

Patient Problem Insufficient Information (4580)

Event Date 02/12/2024

Event Type  Injury  

Event Description

It was reported there was a 15-20 minute delay in surgery.

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

The agent reported that "cs implant wouldn't come off the thread inserter.Implant was loaded loose.Patient has unusually hard bone.I was able to remove it with a set of pliers after the case." this event occurred during the assembly of components, near the patient.No response was received by the surgeon.Agent will continue to request a response.The surgery was completed as intended, with a fifteen-to-twenty-minute delay.The implant was inspected prior to use and was deemed acceptable for use based on its appearance.The agent was present during surgery and was able to source a suitable replacement device.Rma evaluation: the implant was returned to djo and after further examination, the implant shows scratches on the bottom probably from the pliers when surgeon was trying to remove from inserter.The humeral neck was not returned a review of the implant's device history record (dhr) revealed the instrument, when released for use, met design and manufacturing requirements.There were no ncmrs associated with the production of this instrument.Complaint database review showed ten previous complaints but there were no indications that this instrument has a design or material deficiency.S800-revision surgery, 10 the root cause of this complaint is likely attributable to surgical technique and how the implant was loaded on the inserter.It could be probable that forceful use could have contributed the implant being stuck.This is not an event associated with a product failure, malfunction, or issue.

• Brand Name: ALTIVATE ANATOMIC CS, HUMERAL STEM AND NECK KIT, SIZE 3
• Type of Device: PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM
• 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: 18871719
• MDR Text Key: 337291538
• Report Number: 1644408-2024-00279
• Device Sequence Number: 1
• Product Code: PKC
• UDI-Device Identifier: 00190446648321
• UDI-Public: 00190446648321
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193226
• 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: 04/25/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 520-08-024
• Device Lot Number: 1993A1050
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 03/08/2024
• Supplement Dates Manufacturer Received: 04/05/2024
• Supplement Dates FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Sex: Male