MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 42MM HUM LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-42-00
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994)
Date of Event	07/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation approximately 39 months after a right shoulder replacement surgery, the patient underwent an arthroscopic lysis of adhesions and debridement to address paint, stiffness, disfunction and tightness.There were surgical or medical interventions reported.There is no additional information available.
Additional Manufacturer Narrative
D10: 320-42-00 - equinoxe reverse 42mm humeral liner +0, (b)(6), 320-10-10 - equinoxe reverse tray adapter plate tray +10, (b)(6), 300-01-11 - equinoxe, humeral stem primary, press fit 11mm, (b)(6), 320-02-42 - rs expanded glenosphere 42mm, +4mm offset, (b)(6), 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm, (b)(6), 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm, (b)(6), 320-15-01 - eq rev glenoid plate, (b)(6), 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm, (b)(6), 320-20-00 - eq reverse torque defining screw kit, (b)(6), 321-20-00 - equinoxe reverse shoulder drill kit, (b)(6), 320-15-05 - eq rev locking screw, (b)(6), 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.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 definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
The product associated with the reported event is within the scope of recall z-1422-2024; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.This follow-up report is being submitted to relay additional and/or corrected information.B3: date of event is unknown.The reason for the procedure cannot be confirmed but may be due to prothesis wear and/or the inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient related considerations could not be assessed as the devices were not available for evaluation and images, radiographs and relevant clinical information was not provided.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 42MM HUM LINER +0
• 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, INC; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21797736
• Report Number: 1038671-2025-01768
• Device Sequence Number: 15516293
• Product Code: KWT
• UDI-Device Identifier: 10885862086693
• UDI-Public: 10885862086693
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2025

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
• Device Catalogue Number: 320-42-00
• 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: 10/04/2024
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 04/08/2025
• Supplement Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2022
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown