MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE CAGE GLENOID CEMENTED; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	314-13-03
Health Effect - Clinical Codes	Erosion (1750); Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
Total shoulder arthroplasty procedure.Showed severe signs of erosion of the glenoid.Multiple cystic erosive changes within the glenoid, largest individual cystic erosion of 1.2cm.Glenoid pegs/screws show severe signs of loosening and erosion.Surgeon says too much bone loss to do second shoulder replacement.

• Brand Name: EQUINOXE CAGE GLENOID CEMENTED
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.
• MDR Report Key: 19212526
• Report Number: MW5154427
• Device Sequence Number: 7025660
• Product Code: KWS
• UDI-Device Identifier: 10885862172686
• UDI-Public: 10885862172686
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date (Section B): 04/29/2024

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
• Device Model Number: 314-13-03
• Device Lot Number: 6342044
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2024
• Patient Sequence Number: 1
• Patient Sex: Unknown