MAUDE Adverse Event Report: EXACTECH, INC. GLENOSPHERE 38MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	320-06-38
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had an initial left tsa on (b)(6) 2022.The stem, poly and tray were revised on (b)(6) 2023 due to total shoulder dislocation.There was no reported breakage of devices or surgical delay/prolongation.The patient was last known to be in stable condition following the event.No other patient information/medical history provided.
Additional Manufacturer Narrative
Pending investigation.A193237 300-30-08 - equinoxe preserve stem 8mm.A300104 320-10-00 - equinoxe reverse tray adapter plate tray +0.A163919 320-15-05 - eq rev locking screw.6913850 320-15-07 - sup/post aug plate, l rs glenoid baseplate.A232101 320-20-00 - eq reverse torque defining screw kit.S393828 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.6154853 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.A174174 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.S384740 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.A254659 320-38-03 - 145-deg pe 38mm hum liner +2.5.A287283 321-52-07 - 3.2mm drill bit sterile.
Additional Manufacturer Narrative
H3: based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the dislocation and subsequent closed reduction cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition and the result of loosened supporting ligaments and muscles, which allowed for dislocation occurring due to the significant ligament reconstruction.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: b, c, d, g.The cause of the patient¿s shoulder dislocation and subsequent revision reported cannot be conclusively determined; however, it may be due to soft tissue imbalance, patient anatomy, implant positioning, and/or implant selection.Dislocation is a known risk, as outlined in the ifu.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: GLENOSPHERE 38MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-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: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16293307
• Report Number: 1038671-2023-00099
• Device Sequence Number: 12413549
• Product Code: KWS
• UDI-Device Identifier: 10885862563699
• UDI-Public: 10885862563699
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2025

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 Model Number: 320-06-38
• Device Catalogue Number: 320-06-38
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/13/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2023
• Supplement Date Received by Manufacturer: 03/09/2023; 07/09/2025
• Initial Report FDA Received Date: 02/03/2023
• Supplement Report FDA Received Date: 03/28/2023; 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2022
• 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 H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown