MAUDE Adverse Event Report: EXACTECH, INC. RS EXPANDED GLENOSPHERE 38MM, +4MM OFFSET; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-02-38
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report number: 1038671-2024-04253 this follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h6 h10 the following sections were corrected: b2 g4:510k h6 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 as stated in the experience report.Other contributing factors may be 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.
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): a429693 308-01-08 - 8x80mm distal stem modular cemented, a335126 308-05-19 - distal fixation ring ha 19.5, b032561 308-10-00 - med prox body +0, a325338 308-10-50 - 50mm middle segment modular, b124301 308-10-75 - 75mm middle segment modular, 7092779 308-16-25 - taper locking screw 125, b047306 320-10-00 - equinoxe reverse tray adapter plate tray +0, b118905 320-15-01 - eq rev glenoid plate, b020949 320-15-05 - eq rev locking screw, b077425 320-20-00 - eq reverse torque defining screw kit, s532378 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm, b080187 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm, b019474 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm, s525734 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm, a464891 321-20-00 - equinoxe reverse shoulder drill kit, a920763 321-52-09 - 3.2mm k-wire, trocar tip.
Event or Problem Description
It was reported that this patient's right shoulder was revised approximately one months post operation.Hrp was dislocating due to lack of soft tissue tension.Patient revised to exactech devices: liner and glenosphere were upsized to 42mm.Patient was last known to be in stable condition following the event.Product not returning: discarded at the hospital.

• Brand Name: RS EXPANDED GLENOSPHERE 38MM, +4MM OFFSET
• 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20616861
• Report Number: 1038671-2024-04252
• Device Sequence Number: 20671098
• Product Code: KWS
• UDI-Device Identifier: 10885862186751
• UDI-Public: 10885862186751
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K110708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 01/15/2025

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: 320-02-38
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female