MAUDE Adverse Event Report: ENCORE MEDICAL L.P ALTIVATE REVERSE, HUMERAL STEM, SMALL SHELL, SZ 8X48MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	533-08-048
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The agent reported "(dr said that the poly was extremely difficult to impact fully into the stem.Gender: female/age: 74)." the items were left in the patient, this event occurred near the patient.The incident did cause a 2 min delay in surgery, surgery was completed as intended, there was no risk or adverse event reported and the device was inspected prior to surgery and was found to be acceptable.Surgical devices condition can be determined while being used for its intended purpose.This incident does not indicate a product deficiency, failure or issue.No further action is deemed necessary at this time.A review of the device history records (dhr) revealed, when released for use, the item(s) met design and manufacturing requirements.Complaint database review showed no previous complaints with the same description of the event.This event is attributable to the poly being extremely difficult to impact fully into the stem.This is not an event associated with a product failure, malfunction or issue.
Event or Problem Description
Primary surgery - part left in patient.

• Brand Name: ALTIVATE REVERSE, HUMERAL STEM, SMALL SHELL, SZ 8X48MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER 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: 16746688
• Report Number: 1644408-2023-00492
• Device Sequence Number: 19649643
• Product Code: KWS
• UDI-Device Identifier: 00190446334965
• UDI-Public: 00190446334965
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K190290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/13/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 533-08-048
• Device Catalogue Number: 533-08-048
• Device Lot Number: 1491A1210
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: 74 YR
• Patient Sex: Female