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

Model Number	520-01-006
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason of this revision surgery was reported as an infection.The previous surgery to alleviate the infection and this surgery occurred over 3.9 months apart.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 device was disposed of at the hospital and not made available to djo surgical for examination.This investigation was received and has been identified as the second stage of a two stage process to alleviate a patient infection.This process consists of the removal of implants that are present in the infected joint, building a spacer to fill the joint and coating the spacer with antibiotics which is then implanted into the affected joint.The first stage surgery was performed.Upon the surgeon's determination that the infection is under control and the tissue is normalized the antibiotic construct is removed and new components are implanted.There was no new information from the previous surgery 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.
Event or Problem Description
Third revision surgery: this patient has been revised three different occasions since his original date of surgery.The original surgery was an reverse shoulder prosthesis and needed to be revised.Patient was revised nearly a year and a half later.All reverse shoulder prosthesis components were removed and hemi cement coated spacer was placed to combat infection, all components are being removed and replaced with standard reverse shoulder prosthesis components.

• Brand Name: TURON SHOULDER
• Common Device Name: TURON PRIMARY HUMERAL STEM, SZ 6
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 9010363
• Report Number: 1644408-2019-00860
• Device Sequence Number: 2254823
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2019

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: 06/30/2020
• Device Model Number: 520-01-006
• Device Catalogue Number: 520-01-006
• Device Lot Number: 533G1042
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 09/12/2019
• 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: Other; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 150