MAUDE Adverse Event Report: ENCORE MEDICAL L.P. TURON PEGGED GLENOID IMPLANT; TURON PEGGED GLENOID IMPLANT, SIZE 42

Catalog Number	520-01-242
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to previous report number 1644408-2023-01065; 520-01-242, s800 - revision surgery, revision surgery.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 implant failure.

• Brand Name: TURON PEGGED GLENOID IMPLANT
• Common Device Name: TURON PEGGED GLENOID IMPLANT, SIZE 42
• 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: 19717060
• Report Number: 1644408-2024-01057
• Device Sequence Number: 8130341
• Product Code: KWS
• UDI-Device Identifier: 00888912024952
• UDI-Public: 00888912024952
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K123982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 07/10/2024

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: 03/28/2020
• Device Catalogue Number: 520-01-242
• Device Lot Number: 191G1097
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2015
• 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: 878C1550; 520-46-016 LOT: 917C1037
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female