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

Catalog Number 320-36-00

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 11/29/2023

Event Type  Injury  

Event Description

As reported, the patient had an initial tsa on (b)(6) 2020.The patient was revised on (b)(6) 2023 due to poly wear, which caused instability.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.The event.No other patient information/medical history reported.

Manufacturer Narrative

H3: pending investigation.D10: 5672297 - 300-30-14 - equinoxe preserve stem 14mm 6487699 -315-35-00 - glnd kwire 6537562 - 320-10-00 - equinoxe reverse tray adapter plate tray +0 6537145 - 320-15-05 - eq rev locking screw 6575030 - 320-20-00 - eq reverse torque defining screw kit 6302974 - 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm s080215 - 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm 5891478 - 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm s086710 - 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm 6464276 - 320-31-36 - glenosphere, 36mm 6440092 - 320-35-04 - small posterior augment glenoid plate, right 6466966 - 320-36-00 - 145-deg pe 36mm hum liner +0 6520536 - 531-20-00 - shldr gps rvrs drill kit 6617433 - 531-78-20 - shouldr gps hex pins kit 2025520308 - a10012 - gps implant kit v2 2039220041 - a10012 - gps implant kit v2.

• Brand Name: 36MM HUMERAL LINER +0 UNCONSTRAINED
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18334731
• MDR Text Key: 330598218
• Report Number: 1038671-2023-02994
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093275
• 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
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-36-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/16/2020
• 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
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female