MAUDE Adverse Event Report: ENCORE MEDICAL L.P. ALTIVATE ANATOMIC SHOULDER; ALTIVATE ANATOMIC, OFFSET HUMERAL HEAD, 46X18

Model Number	520-46-318
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Complaint - these items were not charged to the hospital, the head kept disengaging from the trunnion upon impaction.Another head and neck were opened and worked perfectly.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this complaint was reported as head kept disengaging from the trunnion upon impaction.The healthcare professional indicated this event occurred during surgery, near the patient.No risk, adverse event, or negative outcome were reported.There was a three to four minute delay in surgery but the surgery was completed as intended.The devices were inspected prior to use and were deemed acceptable for use based on their appearance.The devices were returned to manufacturer and evaluated by registered medical assistant (rma) at djo surgical.A review of the device history records (dhr) show that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non conforming material reports (ncmr) associated with the products that may have contributed to the reported event.Customer complaint history of the reported devices showed no present trends or on-going issues that are needing a review.Both products were inspected and found to be on the nominal for all dimensions.It is difficult to determine what the root cause of the complaint is, it is likely that there was tissue preventing the tapers from properly engaging.There are multiple factors that may contribute to an event that are outside the control of djo surgical.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.The revision surgery was completed successfully.Rma examination: the reported devices were returned to djo surgical for examination.The devices were inspected and found to be on the nominal for all dimensions.Non conformance could not be confirmed, neck and head were able to engage easily.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: ALTIVATE ANATOMIC SHOULDER
• Common Device Name: ALTIVATE ANATOMIC, OFFSET HUMERAL HEAD, 46X18
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer Contact: kiersten soderman ; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 12432821
• Report Number: 1644408-2021-00941
• Device Sequence Number: 19745646
• Product Code: KWS
• UDI-Device Identifier: 00190446176220
• UDI-Public: (01)00190446176220
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 01/17/2022

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 Model Number: 520-46-318
• Device Catalogue Number: 520-46-318
• Device Lot Number: 878U1081
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 520-07-000 LOT 888U1560; 520-07-000 LOT 888U1560
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 68 YR
• Patient Sex: Female