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

Catalog Number	314-13-35
Medical Device Problem Codes	Unstable (1667); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Subluxation (4525); Joint Laxity (4526); Muscle/Tendon Damage (4532)
Date of Event	10/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Approximately 1 year 6 months after an initial right tsa, the patient presented with instability/subluxation from a rotator cuff tear and superior and anterior migration of the humeral head.The outcome of this event was resolved by standard total revision with preserves stem.The case report indicates the event is possibly related to the device(s) and/or to the procedure.
Additional Manufacturer Narrative
(d10) concomitant device(s): 310-02-50 - equinoxe, humeral head tall, 50mm (beta): 5929415.300-10-45 - equinoxe replicator plate 4.5mm o/s: 6343808.300-30-07 - equinoxe preserve stem 7mm: 5877234.300-20-02 - equinox square torque define screw drive kit: 6310852.531-78-20 - shouldr gps hex pins kit: 6319672.A10012 - gps implant kit v2: 11000619057.

• Brand Name: EQUINOXE SHOULDER COMPONENTS
• 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; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19633430
• Report Number: 1038671-2024-02194
• Device Sequence Number: 7065478
• Product Code: KWS
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K162726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/29/2024
• Device Catalogue Number: 314-13-35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/14/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2024
• Supplement Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 07/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2019
• 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
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 114 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White