MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE SMALL GLENOID PLATE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	320-35-01
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646); Aseptic loosening (4883)
Date of Event	03/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial total shoulder replacement on the left side.Subsequently, the patient experienced aseptic glenoid loosening.It was also noted by the patient that they developed progressively worsening pain without inciting event.As a result, approximately 3 years after initial shoulder replacement, the patient underwent a left shoulder revision.No further impact to the patient was reported.No other information is available.
Additional Manufacturer Narrative
(d10) concomitant devices: 300-30-06 - equinoxe preserve stem 6mm: (b)(6), 320-36-03 - 145-deg pe 36mm hum liner +2.5: (b)(6), 320-10-00 - equinoxe rev tray adapter plate +0: (b)(6), 320-31-36 - glenosphere, 36mm: (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: h6, h11.The following sections were corrected: h6 - clinical codes.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A review of exactech¿s non-conformance reporting database was conducted and no reports for the glenoid baseplate packaging/manufacturing lots were found.Therefore, the loosening reported does not appear to be manufacturing-related.A review of complaint history was unable to be performed as the relevant device and event information was unknown.A definitive root cause was unable to be determined; however, may have resulted from loosening: properly functioning implants depend on their appropriate fixation to the bone; fixation can be achieved by cementing the implant onto the prepared bone or by biologic (non-cemented) fixation.Although implants are firmly fixed at the initial surgery, they may become loose over time.In a process called aseptic (non-infected) loosening, the bond of the implant to the bone is destroyed.Aseptic loosening can be the result of inadequate initial fixation, mechanical loss of fixation over time, or biologic loss of fixation caused by particle-induced osteolysis around the implant.When the prosthesis becomes loose, the patient may experience pain, change in alignment, and instability.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE SMALL GLENOID PLATE
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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
• MDR Report Key: 21742444
• Report Number: 1038671-2025-01709
• Device Sequence Number: 14464659
• Product Code: PHX
• UDI-Device Identifier: 10885862534866
• UDI-Public: 10885862534866
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2025

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: 320-35-01
• 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: 03/12/2025
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2021
• 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: Hospitalization
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Race: White