MAUDE Adverse Event Report: EXACTECH, INC. GLENOSPHERE 42MM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-06-42
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	10/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient felt a pop and the poly dissociated on the right side and had to be revised.A new poly and glenosphere were implanted due to metal debris.All fragments, parts and pieces were removed.There was no reported surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Pending investigation.Concomitants: 320-42-00 - 145-deg pe 42mm hum liner +0.300-01-13 - equinoxe, humeral stem primary, press fit 13mm (b)(6).320-10-00 - equinoxe reverse tray adapter plate tray +0 (b)(6).320-15-01 - eq rev glenoid plate (b)(6).320-15-05 - eq rev locking screw (b)(6).320-20-00 - eq reverse torque defining screw kit (b)(6).320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm (b)(6).320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm (b)(6).320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm (b)(6).320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm (b)(6).321-52-07 - 3.2mm drill bit sterile (b)(6).321-52-09 - 3.2mm k-wire, trocar tip (b)(6).

• Brand Name: GLENOSPHERE 42MM
• Common Device Name: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20432037
• Report Number: 1038671-2024-03957
• Device Sequence Number: 7608933
• Product Code: KWT
• UDI-Device Identifier: 10885862563712
• UDI-Public: 10885862563712
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K193098
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/11/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 320-06-42
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 10/11/2024
• Date Device Manufactured: 08/05/2022
• 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: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male