MAUDE Adverse Event Report: EXACTECH, INC. SPECIFIC DEVICE NOT REPORTED; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-36-03
Medical Device Problem Codes	Unstable (1667); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	11/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 3 months post op initial right tsa, this 64 y/o female patient was revised.Patient dislocated and became unstable.Surgeon removed the small proximal body, +5 humeral adapter tray, +2.5mm 36mm liner.To create greater stability the surgeon added a 25mm hrp middle segment, +0 proximal humeral body small, +0mm humeral adapter tray, 40mm +0 constrained humeral liner.Surgeon went from a 36mm djo glenosphere to a 40mm glenosphere.Patient was last known to be in stable condition following the event.Product not returning - hospital policy.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation (d10) concomitant device(s): a487204 - 308-01-09 - 9x80mm distal stem modular cemented.(b)(6) - 308-05-17 - distal fixation ring ha 17.5.(b)(6) - 308-09-00 - small prox body +0.(b)(6) - 308-10-25 - 25mm middle segment modular.(b)(6) - 308-10-75 - 75mm middle segment modular.(b)(6) - 308-16-00 - taper locking screw 100.(b)(6) - 320-10-05 - equinoxe reverse tray adapter plate tray +5.(b)(6) - 320-20-00 - eq reverse torque defining screw kit.(b)(6) - 320-36-03 - 145-deg pe 36mm hum liner +2.5.
Additional Manufacturer Narrative
The cause of the patient's shoulder dislocation and instability 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 and instability are known risks, as outlined in the ifu.D1: corrected.D4/d6: device, serial #, udi #, expiration, implant and explant dates unknown.G3: manufactured dates unknown.G4: pma 510k cannot be determined.H6: corrected health effect, medical device, component, and investigation clinical codes.

• Brand Name: SPECIFIC DEVICE NOT REPORTED
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18278680
• Report Number: 1038671-2023-02920
• Device Sequence Number: 20380797
• Product Code: KWT
• UDI-Device Identifier: 10885862086624
• UDI-Public: 10885862086624
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K093275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 320-36-03
• 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: 11/16/2023
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2022
• 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
• Patient Age: 64 YR
• Patient Sex: Female