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

Model Number	520-01-238
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/21/2019
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 - removed all implants except the stem, due to dislocating.
Additional Manufacturer Narrative
The reason for this revision surgery was due to dislocation.The previous surgery and the surgery detailed in this event occurred 6 years and 11 months apart.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The surgery was completed as intended and without incident.The device was disposed of at the hospital and not made available to djo surgical for examination.A review of the device history records show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There was a ncmr#19420 associated with the concomitant part 520-00-000, neck, humeral, neutral, which documents that out of 20 parts lot, all parts were rejected as parts are suspected to have pending results on air gage set-up investigation.The parts were accepted after suitable rework operation.The devices were verified to have gone through an acceptable sterilization process and were within its expiration dates 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.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 indication 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 LP; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 9496406
• Report Number: 1644408-2019-01264
• Device Sequence Number: 1839306
• Product Code: KWS
• UDI-Device Identifier: 00888912024945
• UDI-Public: (01)00888912024945
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2020

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: 03/28/2018
• Device Model Number: 520-01-238
• Device Catalogue Number: 520-46-116
• Device Lot Number: 923C1012
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 12/26/2019
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 01/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR