MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-06-42

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 10/25/2022

Event Type  Injury  

Event Description

It was reported via clinical study that the 64 yo male patient experienced a healing problem (w/o proved infection).The patient started developing shoulder pain around (b)(6) 2022 and as a result stopped working out.Since the pain has persisted the patient proceeded with ultrasound guided left shoulder aspiration which was noted with +c acnes.The patient was revised on (b)(6) 2023 (left explant tsa, i&d, and antibiotic spacer on (b)(6) 2022).The outcome was last known as resolved on 01/20/2023.

Manufacturer Narrative

D10.Concomitants: 300-30-07 - equinoxe preserve stem 7mm; 320-42-00 - equinoxe reverse 42mm humeral liner +0; 320-10-00 - equinoxe reverse tray adapter plate tray +0; 320-25-03.

• Brand Name: EQUINOXE
• Type of Device: 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 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 16999805
• MDR Text Key: 315912271
• Report Number: 1038671-2023-01132
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/24/2023

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 Operator: Health Professional
• Device Catalogue Number: 320-06-42
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2023
• Initial Date FDA Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White