MAUDE Adverse Event Report: EXACTECH, INC. SPECIFIC DEVICE NOT REPORTED; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	300-01-09
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369); Joint Laxity (4526)
Date of Event	10/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant device(s): 320-42-00 - equinoxe reverse 42mm humeral liner +0: 3817260.320-10-05 - equinoxe reverse tray adapter plate tray +5: 3737904.320-01-42 - equinoxe reverse 42mm glenosphere: 3818117.320-15-01 - eq rev glenoid plate: 3850744.
Event or Problem Description
Approximately 3 year(s), 8 month(s) and 5 day(s) post-operative of a left rtsa, it was reported via clinical study that the patient experienced a nonunion of periprosthetic fracture orif.Patient was initially being treated nonoperatively for the periprosthetic fracture but had acute worsening of pain and feelings of instability.Previously, this patient experienced three separate humeral fractures with unexplained pain, underwent several open reductions as well as was seen in the emergency department.All earlier events were resolved.The patient underwent a standard reverse revision with the reported removal of the standard humeral stem, humeral tray, and humeral liner.Patient was reported to have been converted from a rtsa to a hrp.The outcome of this event is now considered resolved and the clinical report indicates that this event is possibly related to the device(s) and/or to the procedure.This was reported through clinical trial study data collection activities and no other information is available at this time.
Additional Manufacturer Narrative
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 and investigation clinical codes.H10: 1038671-2024-04264 and 1038671-2024-03029.

• Brand Name: SPECIFIC DEVICE NOT REPORTED
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20631088
• Report Number: 1038671-2024-04297
• Device Sequence Number: 15436117
• Product Code: HSD
• UDI-Device Identifier: 10885862079305
• UDI-Public: 10885862079305
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2025

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 Expiration Date: 02/01/2023
• Device Catalogue Number: 300-01-09
• 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: 10/29/2024
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 07/17/2025
• Date Device Manufactured: 02/06/2013
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Race: White