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
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported there was a 15-20 minute delay in surgery.
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Additional 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
• Common Device Name: 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
• Report Number: 1644408-2024-00279
• Device Sequence Number: 18089119
• Product Code: PKC
• UDI-Device Identifier: 00190446648321
• UDI-Public: 00190446648321
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K193226
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 09/09/2026
• Device Catalogue Number: 520-08-024
• Device Lot Number: 1993A1050
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2024
• Supplement Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Sex: Male