MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 38MM HUM LINER +0; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	322-38-00
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Insufficient Information (4580)
Date of Event	01/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 70 yo female patient, initial reverse left shoulder implanted in (b)(6) 2024, underwent a revision procedure in (b)(6) 2025, approximately 3 months post the initial procedure.The surgeon explanted the glenosphere, tray and liner and went back in with new ones.There were no surgical delays or device breakages during the procedure.The patient was last known to be in stable condition following the event.X-rays were provided.The explanted devices are available for return.A device image was provided.No further information.
Additional Manufacturer Narrative
D10: concomitant devices: 320-06-38 - glenosphere 38mm: (b)(6) 322-10-00 - humeral adapter tray, (b)(6) 320-15-01 - eq rev glenoid plate: (b)(6).Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1/d2a/d2b, h6.Mdr section codes updated/corrected: b, c, d, e.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: 145-DEG PE 38MM HUM LINER +0
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653
• MDR Report Key: 21316008
• Report Number: 1038671-2025-00686
• Device Sequence Number: 8452871
• Product Code: PHX
• UDI-Device Identifier: 10885862593832
• UDI-Public: 10885862593832
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K223833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 322-38-00
• 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: 01/17/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2024
• 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 Age: 70 YR
• Patient Sex: Female