MAUDE Adverse Event Report: EXACTECH, INC. EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-20-30

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 04/25/2023

Event Type  Injury  

Event Description

As reported, approximately 2 years post op initial left tsa, this 72 y/o male patient was revised.The patient originally had an exactech reverse shoulder implanted.At some point the glenosphere became disassociated from the baseplate.Another surgeon in (b)(6) il revised the shoulder implanting the above listed implants on (b)(6) 2021 at (b)(6) (captured in 1038671-2023-01183).The baseplate and stem were not removed but screws were added and a new glenosphere and liner were implanted.After that case the glenoid baseplate became pulled out from the glenoid and was free floating in the shoulder based on xray.Surgeon scheduled a case to revise the shoulder to a hemi on (b)(6) 2023.During the case the surgeon exposed the humerus and removed both the liner and the +0 tray he then moved on to the glenoid where he was able to pull out the glenosphere including the baseplate and all screws.One screw had been broken off in the glenoid from a previous surgery or from when the glenoid component became loose.The broken screw was not retrieved and was left in the glenoid.Surgeon then implanted a 1.5 replicator plate (300-21-00 a197490) and 47 x 18 head (310-01-47 a373263).Surgeon did take 5 cultures to rule out infection, he closed and the checked stability and range of motion with both being good.Patient was last known to be in stable condition following the event.Product no being returned, reason: "patient requested explanted implants".

Manufacturer Narrative

Section h10: (h3) pending evaluation: (d10) concomitant device(s): 4.5 x 30 screw, 320-20-30, s205705, 4.5 x 30 screw, 320-20-30, s205723, 38 glenosphere, 320-06-38, 6917759, locking screw, 320-15-05, 6945519, torque screw, 320-20-00, 6943087, 38 +2.5 liner, 320-38-03, s254497.

• Brand Name: EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM
• 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: 17049326
• MDR Text Key: 316393993
• Report Number: 1038671-2023-01214
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086556
• UDI-Public: 10885862086556
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063569
• 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: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-20-30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/19/2020
• 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 Age: 72 YR
• Patient Sex: Male