MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; TURON KEELED GLENOID, SZ 54MM, EPLUS

Catalog Number	521-01-154
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	08/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to previous report number 1644408-2022-01288; 520-01-242, s800 - revision surgery, s805 - wear/excessive wear, revision surgery; surgical - quality complaints.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.
Event or Problem Description
Revision surgery - due to patient was converted from a total to a reverse due to wear and cuff compromise.

• Brand Name: DJO SURGICAL
• Common Device Name: TURON KEELED GLENOID, SZ 54MM, EPLUS
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 20263730
• Report Number: 1644408-2024-01440
• Device Sequence Number: 12942269
• Product Code: PAO
• UDI-Device Identifier: 00888912145350
• UDI-Public: 00888912145350
• 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: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2024

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: 09/28/2024
• Device Catalogue Number: 521-01-154
• Device Lot Number: 797N1005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2014
• 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: 878C1443; 520-01-008 LOT: 454G1080; 520-54-022 LOT: 940C1013
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male