MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 38MM HUM LINER +2.5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-38-03
Medical Device Problem Codes	Unstable (1667); Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	07/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(h3) the cause of the patient¿s shoulder dislocation and subsequent revision reported cannot be conclusively determined; however, it may be due to a soft tissue imbalance, implant positioning, and/or implant size selection.Instability and total joint dislocation are known harms, as outlined in the ifu and risk file.The prosthesis wear noted on the explanted device appears to be secondary to abnormal articulation within the joint following the dislocation event.(d10) concomitant device(s): 320-01-38 equinoxe reverse 38mm glenosphere, (b)(6); 320-15-05 - eq rev locking screw, (b)(6); 300-01-11 - equinoxe, humeral stem primary, press fit 11mm, (b)(6); 320-10-00 - equinoxe reverse tray adapter plate tray +0, (b)(6); 320-15-04 - rs glenoid plate post aug, 8 deg, right, (b)(6); 320-20-00 - eq reverse torque defining screw kit, (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); 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm, (b)(6); 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm, (b)(6).
Event or Problem Description
It was reported that approximately 1 year port op this patient was experiencing issues with their shoulder.The surgeon had several plans prior to surgery however due to the poor bone quality, he elected to leave the stem insitu and drill a burr hole (2mm) through the lateral fin of the stem in order to run a suture through and onto the greater tuberosity.He also removed the glenosphere and tried a +4mm glenosphere.This created too much pressure on the gt, so he went back to the original glenosphere.He then removed the liner and identified excessive wear on the medial aspect which had been articulating whilst displaced.He tried a 38mm constrained humeral liner +2.5mm and was happy with the stability.He implanted this liner and reduced the construct and was happy with the result.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The product associated with the reported event is within the scope of recall z-1418-2024; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The cause of the patient¿s shoulder dislocation and subsequent revision reported cannot be conclusively determined; however, it may be due to a soft tissue imbalance, implant positioning, and/or implant size selection.Instability and total joint dislocation are known harms, as outlined in the ifu and risk file.The prosthesis wear noted on the explanted device appears to be secondary to abnormal articulation within the joint following the dislocation event.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: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20611907
• Report Number: 1038671-2024-04236
• Device Sequence Number: 7928705
• Product Code: KWT
• UDI-Device Identifier: 10885862086662
• UDI-Public: 10885862086662
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/14/2026
• Device Catalogue Number: 320-38-03
• 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: 07/07/2022
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2021
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown