MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; BASEPLATE, GLENOID HA-COAT, RSP, 6.5MM X 30MM

Catalog Number	508-32-104
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	05/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery: due to infection, the 6.5 screw broke off during the removal of baseplate, 30 minute delay in surgery.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to report number 1644408-2023-00108; 508-32-204, s808 - infection, s801 - device cracked/broke, revision surgery; surgical - quality complaints.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: BASEPLATE, GLENOID HA-COAT, RSP, 6.5MM X 30MM
• 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: 22682961
• Report Number: 1644408-2025-01156
• Device Sequence Number: 9565789
• Product Code: PHX
• UDI-Device Identifier: 00888912024754
• UDI-Public: 00888912024754
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K051075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 07/31/2025

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 Expiration Date: 12/21/2022
• Device Catalogue Number: 508-32-104
• Device Lot Number: 868B1549
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/22/2016
• 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: 506-03-114 LOT: 831C1344.; 506-03-118 LOT: 832C1286.; 506-03-126 LOT: 834C1301.; 506-03-126 LOT: 834C1302.; 508-00-032 LOT: 855C2039.; 508-32-101 LOT: 862C2208.; 510-00-010 LOT: 980F1301.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male