MAUDE Adverse Event Report: EXACTECH, INC. SUP/POST AUG PLATE, R RS GLENOID BASEPLATE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	SUP/POST AUG PLATE, R RS GLENOID BASEPLATE
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Metal Related Pathology (4530)
Date of Event	04/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant products 6612419 - 300-01-09 - equinoxe, humeral stem primary, press fit 9mm 6589796 - 320-01-36 - 36mm glenosphere 6677928 - 320-10-00 - equinoxe reverse tray adapter plate tray +0 6628461 - 320-15-05 - eq rev locking screw 6552988 - 320-15-08 - sup/post aug plate, r rs glenoid baseplate 6642518 - 320-20-00 - eq reverse torque defining screw kit s064650 - 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm s092961 - 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm s066037 - 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm s082295 - 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm s099376 - 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm s113258 - 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm 6635106 - 320-36-00 - 36mm humeral liner +0 unconstrained 6616804 - 531-20-00 - shldr gps rvrs drill kit 6616993 - 531-78-20 - shouldr gps hex pins kit 6706271 - 531-78-20 - shouldr gps hex pins kit 3009120095 - a10012 - gp additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, the 74 year old female patient had an initial right tsa on (b)(6) 2020.The patient was revised on (b)(6) 2024.The patient experienced a scapula fracture and the baseplate and glenosphere spun 180 degrees and was upside down.The inferior screw had broken.There was metalosis as a result of the implant articulating at an acute angle.The stem was still well fixed and there was no presence of infection.The patient is a rheumatoid arthritis sufferer and there was significant resorbtion of the tuberosities.All implants were removed except the stem.A new anatomic replica plate, screw and a cta head were implanted.There was no reported breakage of a device or surgical delay/prolongation.The patient has a hemi arthroplasty now and should be comfortable.Patient range of motion (rom) and function will be very limited however.Sales rep was unable to obtain photos/x-rays.The devices are not available for evaluation due to implants were sent to pathology.
Additional Manufacturer Narrative
H3: the scapular fracture reported is most likely related to the patient¿s underlying condition and bone quality.The fracture of the inferior compression screw is most likely secondary to the scapular fracture and subsequent subjection of the compression screw to high loads resulting in the material fracture.However, this cannot be confirmed as the devices were not available for evaluation and no radiographs or photos were provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were corrected: d4 model number.The scapular fracture reported is most likely related to the patient¿s underlying condition and bone quality.The fracture of the inferior compression screw is most likely secondary to the scapular fracture and subsequent subjection of the compression screw to high loads resulting in the material fracture.However, this cannot be confirmed as the devices were not available for evaluation and no radiographs or photos were provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
Report number: 1038671-2024-02580 this follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: d8.G1.The following sections were corrected: b2.D1.D4.G4: 510k corrected.H4.H6.The scapular fracture reported is most likely related to the patient¿s underlying condition and bone quality.The fracture of the inferior compression screw is most likely secondary to the scapular fracture and subsequent subjection of the compression screw to high loads resulting in the material fracture.However, this cannot be confirmed as the devices were not available for evaluation and no radiographs or photos were provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: SUP/POST AUG PLATE, R RS GLENOID BASEPLATE
• Common Device Name: 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 19260490
• Report Number: 1038671-2024-01089
• Device Sequence Number: 2569572
• Product Code: KWS
• UDI-Device Identifier: 10885862242563
• UDI-Public: 10885862242563
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K131575
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/12/2024

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: SUP/POST AUG PLATE, R RS GLENOID BASEPLATE
• Device Catalogue Number: 320-15-08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2024
• Supplement Date Received by Manufacturer: 07/29/2024; Not provided; 12/10/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 08/12/2024; 12/11/2024; 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 55 KG