MAUDE Adverse Event Report: ENCORE MEDICAL L.P. ALTIVATE SHOULDER; ALTIVATE ANATOMIC, NEUTRAL HUMERAL HEAD, 46X16

Model Number	520-46-216
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this revision surgery was due to the humeral head popping off.The previous surgery and the surgery detailed in this investigation occurred 1.1 year apart.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery.There are no reported pre-existing patient health conditions.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was disposed of at the hospital and not made available to djo surgical for examination.A review of the implant device history records (dhr), shows 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 (ncmrs) associated with the product that may have contributed to the reported event.The device was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of use during the previous surgery.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The root cause of this complaint was a revision surgery due to humeral head popping off.There were no findings during this investigation that indicate that the reported device was defective.There are multiple factors that may contribute to an event that are outside of 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.
Event or Problem Description
Revision surgery - due to the humeral head popping off due to patient reaching behind her back.
Additional Manufacturer Narrative
D10 - adding concomitant part 402438.

• Brand Name: ALTIVATE SHOULDER
• Common Device Name: ALTIVATE ANATOMIC, NEUTRAL HUMERAL HEAD, 46X16
• 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: teffany hutto ; 9800 metric blvd; austin, TX 78758-5445
• MDR Report Key: 8425219
• Report Number: 1644408-2019-00198
• Device Sequence Number: 13528935
• Product Code: PAO
• UDI-Device Identifier: 00190446176114
• UDI-Public: (01)00190446176114
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K162024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• 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): 05/26/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/14/2023
• Device Model Number: 520-46-216
• Device Catalogue Number: 520-46-216
• Device Lot Number: 948U1016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 03/15/2019
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2017
• 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: 402438 COBALT MV BONE CEMENT 40GM B; 520-07-000, LOT 888U1075; 520-10-000, LOT 851U1020; 521-07-246, LOT 892U1022; 520-07-000, LOT 888U1075; 520-10-000, LOT 851U1020; 521-07-246, LOT 892U1022
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female