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

Model Number 36MM HUMERAL LINER +0 UNCONSTRAINED

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 09/06/2023

Event Type  Injury  

Manufacturer Narrative

Section d10: concomitant products: - eq reverse tray adaptor +0mm (cat# 320-10-00 / serial# (b)(6)) - eq reverse locking screw (cat# 320-15-05 / serial# (b)(6)) - eq reverse torque defining screw kit (cat# 320-20-00 / serial# (b)(6)) - eq reverse compression locking screw w/ cap 4.5mmx18mm (cat# 320-20-18 / serial# (b)(6)) - eq reverse compression locking screw w/ cap 4.5mmx18mm (cat# 320-20-18 / serial# (b)(6)) - eq reverse compression locking screw w/ cap 4.5mmx22mm (cat# 320-20-22 / serial# (b)(6)) - eq reverse compression locking screw w/ cap 4.5mmx22mm (cat# 320-20-22 / serial# (b)(6)) - glenosphere 36mm (cat# 320-31-36 / serial# (b)(6)) - small glenoid plate (cat# 320-35-01 / serial# (b)(6)) additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported, approximately three years post initial right tsa, the 80 y/o female patient presented back to surgeon's office with complaints of pain and dissatisfaction with their right reverse tsa.Upon examination and imaging, the surgeon believed the patient's glenoid positioning was too superior, this led to inferior scapular notching of the poly liner implant onto the scapular bone.Evidence of bone reabsorption and osteolysis due to poly wear is present.The surgeon felt the baseplate implant was unstable and loose on imaging.The surgeon would like it reported that this patient obtained a scapular spine fracture as well.The patient was scheduled for a revision right reverse tsa surgery.During the revision surgery, the joint was exposed.The humeral liner, torque screw, and tray were removed from the stem.The stem was checked for stability.The glenoid was then accessed and the locking screw and glenosphere were removed.The locking caps and compression screws were removed and the baseplate showed to be loose in the glenoid bone.There was inferior glenoid bone completely missing due to wear and osteolysis.Cultures were taken throughout the procedure.The baseplate was removed and the joint was irrigated well.The surgeon had to cut and remove the distal coracoid for bone graft and use it in and on the glenoid surface to replace bone before implanting a new competitor's central screw in baseplate.The surgeon used a 36mm competitor's glenosphere and locking screw.The surgeon then went back to the humerus and trailed the exactech 36mm humeral tray and liner to match the 36mm competitor's implant.A new humeral tray was secured with a new torque screw and a new liner was implanted.There was no breakage of device or surgical delay/prolongation.The patient left the or stable.Patient was last known to be in stable condition following the event.Photos and x-ray attached.The devices are not available for evaluation due to devices was discarded by the facility.

• 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 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17840853
• MDR Text Key: 324552416
• Report Number: 1038671-2023-02398
• 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: 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: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 36MM HUMERAL LINER +0 UNCONSTRAINED
• Device Catalogue Number: 320-36-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/23/2020
• 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: EQ PRESERVE STEM 9MM
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female