MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number 300-01-11

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

Patient Problem Bacterial Infection (1735)

Event Date 08/18/2022

Event Type  Injury  

Manufacturer Narrative

Device evaluated by manufacturer: pending evaluation.Concomitant device(s): 320-05-01, +5 std left tray, 6864690.320-05-11, +5 lat left tray, 6847791.320-15-05, eq rev locking screw, a017251.320-20-00, eq reverse torque defining screw kit, a070327.320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm, s369770, s369783, s369789, s369790.320-20-42, eq rev compress screw lck cap kit, 4.5 x 42mm, 5727275.320-32-36, expanded glenosphere, 36mm, for small reverse, 7007188.320-35-02, small superior augment glenoid plate, 7318317.320-36-00, 36mm humeral liner +0 unconstrained, 7214120.321-52-07, 3.2mm drill bit sterile, 6603454.321-52-09, 3.2mm k-wire, trocar tip, a010585.521-78-32, threaded pin size 3.0 collarless 2pk, s337812.531-78-20, shouldr gps hex pins kit, a044934.A10012, gps implant kit v2, 04008621298.

Event Description

As reported, this female patient had an index reverse shoulder on her left side was (b)(6) 2022 due to several injustices including proximal humerus fracture.Patient had wound complications with the incision not healing after surgery possibly related to poor protoplasm per surgeon.Surgeon removed the implants and cemented in a antibiotic shoulder spacer after i&d.Patient was last known to be in stable condition.Implants not available without patient release.No films or further information available.

Event Description

As reported, this female patient had an index reverse shoulder on her left side was 7/18/22 due to several injustices including proximal humerus fracture.Patient had wound complications with the incision not healing after surgery possibly related to poor protoplasm per surgeon.Surgeon removed the implants and cemented in a antibiotic shoulder spacer after i&d.There were no reported issues during surgery.Patient was last known to be in stable condition.Implants not available without patient release.No films available.

Manufacturer Narrative

Section h10: (h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of surgical revision for infection cannot be conclusively determined; however, it is most likely related to the patient¿s underlying conditions and noted poor health.Section h11: *the following sections have corrected information: (b5) describe event or problem: as reported, this female patient had an index reverse shoulder on her left side was 7/18/22 due to several injustices including proximal humerus fracture.Patient had wound complications with the incision not healing after surgery possibly related to poor protoplasm per surgeon.Surgeon removed the implants and cemented in a antibiotic shoulder spacer after i&d.There were no reported issues during surgery.Patient was last known to be in stable condition.Implants not available without patient release.No films available.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15372730
• MDR Text Key: 299447233
• Report Number: 1038671-2022-01047
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862079312
• UDI-Public: 10885862079312
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042021
• 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: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 300-01-11
• Device Catalogue Number: 300-01-11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2020
• 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
• Patient Sex: Female