MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 36MM HUM LINER +0; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-36-00
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Bacterial Infection (1735); Erosion (1750); Bone Fracture(s) (1870); Pain (1994); Scar Tissue (2060); Osteolysis (2377); Muscle/Tendon Damage (4532); Implant Pain (4561); Bursitis (4832)
Date of Event	11/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medwatch 330-27000002025-01 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
D10: concomitants: 300-30-06 - equinoxe preserve stem 6mm; (b)(6).320-36-00 - 36mm humeral liner +0 unconstrained; (b)(6).320-10-00 - equinoxe reverse tray adapter plate tray +0; (b)(6).320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm; (b)(6).320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm; (b)(6).320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm; (b)(6).320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm; (b)(6).320-31-36 - glenosphere, 36mm; (b)(6).320-35-01 - small glenoid plate; (b)(6).320-15-05 - eq rev locking screw; (b)(6).320-20-00 - eq reverse torque defining screw kit; (b)(6).
Event or Problem Description
It was reported via a medwatch report, "medwatch (b)(4)", that the patient underwent an initial right total shoulder replacement and right shoulder biceps tenodesis procedure in (b)(6) 2019 to treat an irreparable right rotator cuff tear and biceps tendinitis.Subsequently, the patient reported pain approximately 6 weeks post-operation that was resolved with rest.Approximately 2 years post-operation, the patient again reported pain; however, no evidence of a mechanical problem was observed.Subsequently, the patient reported intense pain that interfered with sleep approximately 3 years post-operation and an mri was obtained.The mri identified subacromial bursitis, containing particulate debris and creating an indolent pattern of erosion of the lateral margin of the acromion process with a stress reaction but no fracture line, as well as chronic tears of the infraspinatus, supraspinatus and subscapularis tendons.Further, ct imaging noted a subacute stress fracture at the far lateral aspect of the acromion with areas of bony resorption.Adjacent degenerative changes of the ac joint as well as fluid extending into the underlying subacromial subdeltoid bursa.No complication of the hardware itself in the setting of reverse type total shoulder arthroplasty.It was discussed with the patient that the particulate debris that showed on the mri may be a reaction to the polyethylene.The patient underwent a revision procedure in (b)(6) 2023, approximately 4 years 4 months post the initial procedure, of the glenosphere, humeral tray, and poly liner.Intraoperatively noted was polyethylene wear on the inferior aspect of the poly, consistent with posterior inferior notching, as well as an exudative material on the soft tissue in the subacromial space.The pathology reports final diagnosis for the synovium right, indicated a tissue reaction to particulate implant material ¿ for the soft tissue: polyethelene debris, mixed small and large particulate.The patient was discharged home on (b)(6) 2023.Approximately 1 week later, the intra-operative cultures obtained during the revision showed broth only cutibacterium (propionibacterium) acnes.The patient was instructed to continuing to take augmentin, on which he had been discharged from the hospital.He was subsequently followed by infectious disease and continued treatment with antibiotics for 6 months.
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, e, f.The revision reported may be the result of the humeral liner wear and infection as reported.However, the series of events and contributing factors to each cannot be confirmed and any potential contributions from user or patient-related contributing factors to the event cannot be evaluated as no radiograph, images, or clinical information was provided.The reason for the infection cannot be conclusively determined; however, it may be related to an underlying patient condition.A review of the sterile certificates was performed for all components.All lots were accepted to the requirements.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 36MM HUM LINER +0
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653
• MDR Report Key: 21120505
• Report Number: 1038671-2025-00186
• Device Sequence Number: 18001266
• Product Code: KWS
• UDI-Device Identifier: 10885862086617
• UDI-Public: 10885862086617
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• 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,Followup,Followup
• Report Date (Section B): 07/03/2025

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: 04/17/2024
• Device Catalogue Number: 320-36-00
• 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; 07/02/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 01/14/2025; 02/24/2025; 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2019
• 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: Required Intervention
• Patient Sex: Male
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White