MAUDE Adverse Event Report: EXACTECH, INC. 36MM HUMERAL LINER +0 UNCONSTRAINED; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-36-00
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Dislocation (2374); Subluxation (4525)
Date of Event	07/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: 308-01-09 - 9x80mm distal stem modular cemented: (b)(6).320-31-36 - glenosphere, 36mm: (b)(6).320-35-01 - small glenoid plate: (b)(6).320-10-00 - equinoxe reverse tray adapter plate tray +0: (b)(6).308-05-20 - distal fixation ring ha 20.5: (b)(6).308-12-00 - med prox body +12.5: (b)(6).308-15-12 - taper locking screw 12.5: (b)(6).320-15-05 - eq rev locking screw: (b)(6).320-20-00 - eq reverse torque defining screw kit: (b)(6).2020-06-25 320-20-18 - 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).320-20-22 - 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).320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm: (b)(6).321-20-00 - equinoxe reverse shoulder drill kit: (b)(6).Asa0030 - sterile disposable containers: (b)(6).13a2101 - cemex system fast genta 70g: (b)(6).Cnl-09 - small cement cannula: (b)(6).
Event or Problem Description
As reported by the equinoxe shoulder study, approximately 0 year(s), 0 month(s), and 20 day(s) post-operative of a left implanted tsa, the patient presented with dislocation.Complete dislocation of prosthesis that requires revision surgery.The outcome of the event was resolved by standard reverse revision of the right shoulder.It is noted that the patient has significant scoliosis, places scapula in protracted positioning, making it at-risk.The clinical report indicates that the event is definitely related to the device(s) and/or to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.
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: a, b, c, d, e, 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: 36MM HUMERAL LINER +0 UNCONSTRAINED
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19568481
• Report Number: 1038671-2024-02004
• Device Sequence Number: 6197471
• Product Code: KWS
• UDI-Device Identifier: 10885862086617
• UDI-Public: 10885862086617
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K093275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

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 Expiration Date: 12/17/2024
• Device Catalogue Number: 320-36-00
• 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: 05/22/2024
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 07/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2019
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Race: White