MAUDE Adverse Event Report: ENCORE MEDICAL L.P. TURON® MODULAR SHOULDER SYSTEM; TURON PEGGED GLENOID, SZ 54MM, EPLUS

Catalog Number	521-01-254
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	07/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this revision surgery was due to a failed turon shoulder.The previous surgery and the revision detailed in this investigation occurred 4 years apart.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery.There are no reported pre-existing patient health conditions.Initial or prolonged hospitalization was required.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 device was disposed of at the hospital and not made available to djo surgical for examination.A review of the implant device history records (dhr) shows that the reported component used in the previous surgery met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to the event.The device was within its expiration date at the time of use during the previous surgery.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The root cause of this complaint was a revision surgery due to failed turon shoulder.There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the event.There are many factors that may contribute to the event that are outside the control of djo surgical such as: patient's age, excessive range-of motion, patient bone deterioration, excessive load or torque, poor bone quality, patient activities or trauma.Invent.
Event or Problem Description
Revision surgery - due to a failed turon shoulder.It required a reverse total shoulder.
Additional Manufacturer Narrative
This mdr was created incorrectly in 2018.The initial report was marked "initial" and "follow up".This fu2 is to state that the original should have been an "initial, 30 day" report.

• Brand Name: TURON® MODULAR SHOULDER SYSTEM
• Common Device Name: TURON PEGGED GLENOID, SZ 54MM, EPLUS
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer Contact: teffany hutto ; 9800 metric blvd; austin, TX 78758-5445 ; 5128346313
• MDR Report Key: 7747832
• Report Number: 1644408-2018-00717
• Device Sequence Number: 12652742
• Product Code: PAO
• UDI-Device Identifier: 00888912145404
• UDI-Public: (01)00888912145404
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K123982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/12/2024

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: 06/30/2019
• Device Catalogue Number: 521-01-254
• Device Lot Number: 802N1016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/16/2018
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/03/2018
• Supplement Report FDA Received Date: 08/03/2018; 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2014
• 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 878C1367; 520-01-010, LOT 455G1121; 520-54-018, LOT 939C1046
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male