MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number CTA HUMERAL HEAD SHORT, 47MM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Loss of Range of Motion (2032); Implant Pain (4561)

Event Date 01/10/2023

Event Type  Injury  

Event Description

It was reported that a 64 yo female patient, initial left shoulder implanted on (b)(6) 2022, underwent a revision procedure on (b)(6) 2023, approximately 5 months post the initial procedure.The hemi shoulder was converted to a reverse shoulder at the patient¿s request.The patient complained of no range of movement and pain on the left shoulder.The surgeon did a reverse on her other side, and she wanted her hemi converted to reverse to feel the benefits of the range of motion that she experiences with her other side.Patient was last known to be in stable condition following the event.The product is not returning as it was discarded by hospital.No further information.

Manufacturer Narrative

Concomitants: 7278662 300-01-09 - equinoxe, humeral stem primary, press fit 9mm.7122028 300-10-45 - equinoxe replicator plate 4.5mm o/s.7273947 300-20-02 - equinox square torque define screw drive kit.Additional information, including the product investigation, will be submitted within 30 days of receipt.

Manufacturer Narrative

After review of additional information received the following sections, have been updated accordingly: h6 based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined; however, it is most likely related to patient conditions.

• Brand Name: EQUINOXE
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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: kate jacobson ; 3523771140
• MDR Report Key: 16312335
• MDR Text Key: 308945551
• Report Number: 1038671-2023-00114
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10885862171511
• UDI-Public: 10885862171511
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K110706
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CTA HUMERAL HEAD SHORT, 47MM
• Device Catalogue Number: 310-21-47
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2017
• 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
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female