MAUDE Adverse Event Report: EXACTECH, INC. RS GLENOID PLATE EXT CAG +10MM CAGE PEG; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	320-10-00
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant device(s): 320-20-30, s271552 - compression screw 4.5 x 30mm; 320-20-22, s123875 - compression screw 4.5 x 22mm; 320-15-05, 6748335 - glenosphere locking screw; 300-01-11, 6764620 -11mm humeral stem; 320-06-38, 6917559 - glenosphere 38mm; 320-38-00, s120082 - quinoxe reverse 38mm humeral liner +0.
Event or Problem Description
As reported, approximately 1 year post op the initial left tsa, this 73 y/o male patient was revised due to pain.No known event has been communicated.The patient did not report a specific event.He presented to the surgeon's office complaining of pain.X-rays showed that the baseplate construct pulled out of the glenoid bone.The baseplate/screw/glenosphere construct pulled out of the glenoid bone.The surgeon removed the humeral liner, torque screw, humeral tray, glenosphere screw, glenosphere, compression screws, & baseplate.The void in the glenoid was grafted with optecure + ccc & cancellous allograft.Then, a replicator plate, torque screw, & humeral head was implanted.The hemiarthroplasty will be left in place to allow the bone graft in the glenoid to heal before revising to a reverse shoulder.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
(h3) the revision reported was likely the result of both poor bone quality and initial implant configuration, which may have prevented biologic fixation between the bone and cage (or healing of the graft to the native glenoid bone), allowed the glenoid components to loosen, and ultimately back out of the glenoid.However, this cannot be confirmed as the devices were not returned for evaluation and immediate post-operative radiographs of the index surgery were not provided.Section h11: the following sections have corrected information: (h6) component code: 4755, part/component/sub-assembly term not applicable (d1) brand name: rs glenoid plate ext cag +10mm cage peg, common device name: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal (d4) catalog number: 320-15-06, serial number: (b)(6), expiration date: 25-feb-2029, unique identifier (udi) #: (b)(4), (d10) concomitant device(s): 320-06-38 - glenosphere 38mm 6917559, 320-10-00 - equinoxe reverse tray adapter plate tray +0 6940176, 320-15-05 - eq rev locking screw 6748335, 320-20-00 - eq reverse torque defining screw kit 6804659, 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm 6250149, 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm s123875, 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm s260170, 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm s271552, 320-38-00 - 145-deg pe 38mm hum liner +0 s120082, (g4) pma/510(k)number: k110708.

• Brand Name: RS GLENOID PLATE EXT CAG +10MM CAGE PEG
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: 14693353
• Report Number: 1038671-2022-00688
• Device Sequence Number: 5175522
• Product Code: KWT
• UDI-Device Identifier: 10885862186706
• UDI-Public: 10885862186706
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K110708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 320-10-00
• Device Catalogue Number: 320-15-06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2022
• Supplement Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male