MAUDE Adverse Event Report: EXACTECH, INC. 36MM GLENOSPHERE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-01-36

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Failure of Implant (1924)

Event Date 04/15/2023

Event Type  Injury  

Manufacturer Narrative

Section h10: (h3) pending evaluation: (d10) concomitant device(s): a217653 300-01-13 - equinoxe, humeral stem primary, press fit 13mm.A053732 320-01-36 - 36mm glenosphere.A227904 320-10-00 - equinoxe reverse tray adapter plate tray +0.A213921 320-15-01 - eq rev glenoid plate.A145777 320-15-05 - eq rev locking screw.A140513 320-20-00 - eq reverse torque defining screw kit.A091112 320-36-00 - 36mm humeral liner +0 unconstrained.

Event Description

As reported, approximately 3 months post op initial tsa, this 86 y/o female patient was revised.Surgeon had suspected infection due to raised crp and lft.Once implants were removed and samples taken, no infection was found.

Manufacturer Narrative

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 suspected infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.

• Brand Name: 36MM GLENOSPHERE
• 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: 17144860
• MDR Text Key: 317341085
• Report Number: 1038671-2023-01380
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086372
• UDI-Public: 10885862086372
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K093275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-01-36
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2022
• 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 Age: 86 YR
• Patient Sex: Female