MAUDE Adverse Event Report: ENCORE MEDICAL L.P. ENCORE SHOULDER; TURON PRIMARY HUMERAL STEM, SZ 6

Model Number	520-01-006
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/08/2021
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
Second revision surgery - old parts used as an antibiotic cement spacer.Patient started draining.Complete removal, irrigation & drainage and reimplantation of new spacer necessary.
Additional Manufacturer Narrative
The reason for this revision surgery was reported as an infection.The previous surgery and the revision surgery detailed in this event occurred 9 days apart.Initial or prolonged hospitalization was required.The healthcare professional indicated there was a serious risk to the patient.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.This investigation was the second stage of a two stage process to alleviate a patient previous infection.This previous process consisted of the removal of implants that are present in the infected joint, then building a antibiotic spacer with new implant components.Since the patient started draining, the antibiotic construct was removed and new components were implanted as a new antibiotic spacer.This surgery was to remove an antibiotic construct and replace them with new components as a antibiotic spacer.There was no product problem and the surgery was completed as intended.Customer complaint history of the reported item 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 an infection.There was no new information regarding cultures identified in the infection, severity of the infection or any patient activities, accidents, or medical contraindications that may have contributed to the previous infection.This event is not the result of a product deficiency, failure or issue.The surgery was completed as intended and without incident.No further action is deemed necessary.Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

• Brand Name: ENCORE SHOULDER
• Common Device Name: TURON PRIMARY HUMERAL STEM, SZ 6
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin 78758 5445
• MDR Report Key: 11435670
• Report Number: 1644408-2021-00127
• Device Sequence Number: 4417148
• Product Code: KWS
• UDI-Device Identifier: 00888912144896
• UDI-Public: (01)00888912144896
• 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: 2021
• 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): 05/06/2021

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: 06/09/2022
• Device Model Number: 520-01-006
• Device Catalogue Number: 520-01-006
• Device Lot Number: 533G1055
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 05/06/2021
• 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 878C1837A; 520-46-020 LOT 919C1098; 520-00-000 LOT 878C1837A; 520-46-020 LOT 919C1098
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 41 YR