MAUDE Adverse Event Report: EXACTECH, INC. 36MM HUMERAL LINER +0 UNCONSTRAINED; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number 320-36-00

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 09/06/2022

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

It was reported that this patient's left shoulder was revised and an antibiotic spacer was inserted.All reverse shoulder parts were explanted.Patient was last known to be in stable condition following the event.Devices will not be retuning due to hospital policy.

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 the shoulder revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.(d10) concomitant device(s): 300-01-12, (b)(6)- equinoxe humeral stem primary press fit 12mm, 320-10-10, (b)(6)- equinoxe reverse tray adapter plate tray +10, 320-15-05, (b)(6)- eq rev locking screw, 320-20-00, (b)(6)- eq reverse torque defining screw kit, 320-20-18, (b)(6)- eq rev compress screw lck cap kit, 4.5 x 18mm, 320-20-26, (b)(6)- eq rev compress screw lck cap kit, 4.5 x 26mm, 320-20-26, (b)(6)- eq rev compress screw lck cap kit, 4.5 x 26mm, 320-31-36, (b)(6)- glenosphere, 36mm.320-35-02, (b)(6)- small superior augment glenoid plate section h11: the following sections have corrected information: (b5) describe event or problem: it was reported that this female patient's left shoulder was revised and an antibiotic spacer was inserted.All reverse shoulder parts were explanted.There were no reported issues during the revision surgical procedure.Patient was last known to be in stable condition following the event.Devices will not be retuning due to hospital policy.Multiple attempts have been made for additional information/ no responses have been received.(d1) brand name: 36mm humeral liner +0 unconstrained (d4) catalog number: 320-36-00, serial number: (b)(6), expiration date: 24-jun-2024, unique identifier (udi) #: (b)(4).(h4) device manufacture date: 28-jun-2019.

Event Description

It was reported that this female patient's left shoulder was revised and an antibiotic spacer was inserted.All reverse shoulder parts were explanted.There were no reported issues during the revision surgical procedure.Patient was last known to be in stable condition following the event.Devices will not be retuning due to hospital policy.Multiple attempts have been made for additional information/ no responses have been received.

• Brand Name: 36MM HUMERAL LINER +0 UNCONSTRAINED
• 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: 15536367
• MDR Text Key: 301108835
• Report Number: 1038671-2022-01226
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086617
• UDI-Public: 10885862086617
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• 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: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 320-36-00
• Device Catalogue Number: 320-36-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2019
• 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 Sex: Female