MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 40MM HUM LINER +0; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	320-40-00
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Osteolysis (2377); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Joint effusion (4849)
Date of Event	12/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 300-30-06 - equinoxe preserve stem 6mm 5678706 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm 6063557 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm 4627826 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm 5535282 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm 5711783 320-35-01 - small glenoid plate 6001833 320-15-05 - eq rev locking screw 5905150 320-40-00 - 145-deg pe 40mm hum liner +0 a605672 320-20-00 - eq reverse torque defining screw kit a723785 320-10-00 - equinoxe reverse tray adapter plate tray +0 a810596 320-15-05 - eq rev locking screw a603317.
Event or Problem Description
It was reported that the patient underwent a revision of a right total shoulder replacement 4 years and 4 months post-op due to pain, poly wear, and infection with continued treatment with antibiotics for 6 months post-op (captured on a separate report).Subsequently, the patient underwent an aspiration of the shoulder approximately 10 months after the revision procedure for continued pain and fluid accumulation (captured on a separate report).Following the aspiration, continued pain was reported and an mri was obtained which showed inflammation around the implant.Approximately 1 month later, the patient underwent a revision of the right total shoulder.Intraoperatively, serosanguineous fluid was noted and intraoperative cultures were all negative.Further, the surgical pathology report noted a soft tissue reaction to polyethylene particulate debris.The patient was implanted with a competitor system.The patient was followed by the pain management service post-operatively and was discharged home approximately 7 days later.The patient was noted to be doing well at his 1 week post-operative visit.Related cases: (rev 1) - mdr# 1038671-2025-00186.(aspiration) mdr# 1038671-2025-00238.
Additional Manufacturer Narrative
Medwatch (b)(4).This follow-up report is being submitted to relay corrected information.The following sections were corrected: b5 - user facility report reference moved to h10 for correction.G2 - report source.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h10.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1/d2a/d2b, h6.Mdr section codes updated/corrected: b, c, d.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not returned to exactech for evaluation and no images, radiographs, or clinical information were 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 40MM HUM LINER +0
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainseville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653
• MDR Report Key: 21149867
• Report Number: 1038671-2025-00239
• Device Sequence Number: 18457264
• Product Code: PHX
• UDI-Device Identifier: 10885862535030
• UDI-Public: 10885862535030
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K180632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/12/2025

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 Catalogue Number: 320-40-00
• 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: 01/02/2025
• Supplement Date Received by Manufacturer: 01/13/2025; 02/10/2025; 06/11/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 01/14/2025; 02/24/2025; 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2023
• 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 Sex: Male
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White