MAUDE Adverse Event Report: ENCORE SHOULDER; HEAD, HUMERAL, NEUTRAL, 50-22

Model Number	520-50-022
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/05/2021
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
Revision surgery - patient complain of having pain and loosens.
Additional Manufacturer Narrative
The reason for this revision surgery was reported as pain and loosening.The previous surgery and the surgery detailed in this event occurred 1 year 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) show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There was an ncmr-51230 associated with the main part #520-50-022, head, humeral, neutral, 50-22 which documents that out of 10 parts lot, 2 parts were rejected, in which one part was rejected due to missing laser etch and other part was rejected due to many scratches on counterbore.Later the rejected parts were reworked and accepted after proper justification.All other items in the respective lot were met with fit, form and function requirements.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 pain and loosening.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 also contribute to an event that are outside the control of djo surgical such as poor bone density, prolonged overhead activities, inadequate soft tissue support, patient activities.There are no indications of a product or process issue affecting implant safety or effectiveness.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: ENCORE SHOULDER
• Common Device Name: HEAD, HUMERAL, NEUTRAL, 50-22
• MDR Report Key: 12627185
• Report Number: 1644408-2021-01105
• Device Sequence Number: 14583392
• Product Code: KWS
• UDI-Device Identifier: 00888912145213
• UDI-Public: (01)00888912145213
• 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: 2020
• Device Explanted 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): 10/28/2021

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: 08/26/2025
• Device Model Number: 520-50-022
• Device Catalogue Number: 520-50-022
• Device Lot Number: 931C1095
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 10/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2019
• 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: 520-00-000 LOT 878C1766.; 520-01-012 LOT 456G1291.; 521-07-246 LOT 892U1140.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR