MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. TURON; TURON PRIMARY HUMERAL STEM, SZ 8

Model Number	520-01-008
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 has been chronically infected, so surgeon did a staged procedure.The patient's infection seemed to be resolved and the surgeon revised him to a reverse shoulder.
Additional Manufacturer Narrative
The reason for this revision surgery was reported as an infection.The previous revision surgery (1st stage) and the revision surgery (2nd stage) detailed in this event occurred 4.4 months apart.The healthcare professional indicated there was an significant adverse event 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.Upon determination that the infection is under control and the tissue is normalized, the construct is removed and new components are implanted.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: TURON
• Common Device Name: TURON PRIMARY HUMERAL STEM, SZ 8
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758 6313
• MDR Report Key: 11882465
• Report Number: 1644408-2021-00490
• Device Sequence Number: 19153588
• Product Code: KWS
• UDI-Device Identifier: 00888912144902
• UDI-Public: (01)00888912144902
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 06/29/2021

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: 07/14/2022
• Device Model Number: 520-01-008
• Device Catalogue Number: 520-01-008
• Device Lot Number: 454G1109
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 06/29/2021
• 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 878C1744; 520-54-026, LOT 942C1053; 520-00-000, LOT 878C1744; 520-54-026, LOT 942C1053
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 66 YR