MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 38MM HUM LINER +2.5; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	320-38-03
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Codes	Joint Dislocation (2374); Subluxation (4525); Joint Impingement (4834)
Date of Event	12/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant devices: 7329534 300-30-13 - equinoxe preserve stem 13mm.A533196 320-15-01 - eq rev glenoid plate.A534388 320-20-00 - eq reverse torque defining screw kit.S433621 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.S431655 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.S355469 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm.A456383 321-52-07 - 3.2mm drill bit sterile.A517831 321-52-10 - 3.2mm k-wire, thd, short 2 k-wires per pack.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.
Event or Problem Description
It was reported that a left equinoxe shoulder prothesis failed in-situ approximately 3 years after implantation.Patient had recurrent dislocation and had scapular notching.Surgeon swapped out the 38 glenosphere to a 42mm +4 lateralized glenoshpere and went to a +5mm humeral adapter tray with a 42mm +0 poly.Patient was last known to be in stable condition following the event.No device was returned for evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, d4, h4, g4, h6.Mdr section codes updated/corrected: a, b, c, d, e, g.The revision reported was likely the result of recurrent dislocations as reported.A secondary finding of prosthesis wear of the liner most likely due to either impingement of the liner against the scapula or wear secondary to abnormal articulation during a dislocation event.However, the recurrent dislocation and series of events cannot be confirmed and potential user-related considerations to the event could not be assessed as the devices were not returned for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: 145-DEG PE 38MM HUM LINER +2.5
• 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: 21117255
• Report Number: 1038671-2025-00172
• Device Sequence Number: 8732866
• Product Code: PHX
• UDI-Device Identifier: 10885862086662
• UDI-Public: 10885862086662
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

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: 12/14/2024
• Device Catalogue Number: 320-38-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2019
• 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: Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male