MAUDE Adverse Event Report: ENCORE MEDICAL L.P. SHOULDER PRIMARY HUMERAL STEM,; HEAD, HUMERAL, OFFSET, 46-16

Model Number	520-46-116
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/24/2019
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
Revision surgery - due to dislocation.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this revision surgery was reported as dislocation.The previous surgery and the surgery detailed in this event occurred 14 days apart.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 devices were disposed of at hospital and not made available to djo surgical for examination.A review of the device history records (dhr) shows that the reported components 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.The devices were verified to have gone through an acceptable sterilization process and were within its expiration date at the time of the previous surgery.Customer complaint history of the reported devices showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a revision surgery due to dislocation.There were no findings during this evaluation that indicate the reported devices were defective.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the event.Due to short time between the previous and revision surgery, it seems that the event may possibly occurred due to patient noncompliance with medical instruction or improper implant selection.There are multiple factors that may contribute to an event that are outside the control of djo surgical such as poor bone density, patient bone deterioration, inadequate soft tissue support, excessive range of motion, prolonged overhead activities, patient activities or trauma.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: SHOULDER PRIMARY HUMERAL STEM,
• Common Device Name: HEAD, HUMERAL, OFFSET, 46-16
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445 TX 78758 5445
• MDR Report Key: 9623117
• Report Number: 1644408-2020-00003
• Device Sequence Number: 13578896
• Product Code: KWS
• UDI-Device Identifier: 00888912025034
• UDI-Public: (01)00888912025034
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K080402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2020

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: 04/09/2024
• Device Model Number: 520-46-116
• Device Catalogue Number: 520-46-116
• Device Lot Number: 923C1135
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/24/2019
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 01/23/2020
• Supplement Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 520-00-000, LOT 878C1775; 520-01-008, LOT 454G1111; 520-00-000, LOT 878C1775; 520-01-008, LOT 454G1111
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR