MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; TURON PEGGED GLENOID, SZ 42MM, EPLUS

Catalog Number	521-01-242
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	07/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery: due to loosening.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to report number 1644408-2022-01676; 521-01-246, s810 - device loosening, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: DJO SURGICAL
• Common Device Name: TURON PEGGED GLENOID, SZ 42MM, 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: stacey bonnell ; 9800 metric blvd; austin, TX 78758 ; 5128346313
• MDR Report Key: 22789912
• Report Number: 1644408-2025-01129
• Device Sequence Number: 9823126
• Product Code: PAO
• UDI-Device Identifier: 00888912145367
• UDI-Public: 00888912145367
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K123982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• 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): 08/12/2025

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 Catalogue Number: 521-01-242
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: UNKNOWN.; 520-01-010 LOT: UNKNOWN.; 520-42-020 LOT: UNKNOWN.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown