MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REV COMPRESS SCREW LCK CAP KIT, 4.5 X 42MM

Model Number	320-20-42
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximal 7 months post op left shoulder replacement, this (b)(6) female patient was revised for a second time due to pain and instability.There was loosening of the glenoid and humeral components with implant breakage (one of the baseplate screws).Patient has poor health.Patient was last known to be in stable condition following the event.Surgeon was happy with the revision result.Devices will not be retuning due to the hospital disposing of them.
Additional Manufacturer Narrative
Pending evaluation concomitant device(s): equinoxe reverse adapter plate tray +5 - 320-10-05, 6230354, equinoxe reverse 38mm glenosphere - 320-01-38, 6747870, equinoxe reverse 38mm humeral liner +2.5 - 320-38-03, s130656, eq rev locking screw - 320-15-05, 6945504, eq reverse torque defining screw kit - 320-20-00, 6926688, equinoxe, humeral primary, press fit 9mm - 300-01-09, 5824106, eq rev compress screw lck cap kit, 4.5 x 30mm - 320-20-30, s270960, eq rev compress screw lck cap kit, 4.5 x 30mm - 320-20-30, s210714, eq rev compress screw lck cap kit, 4.5 x 34mm - 320-20-34, s213651, eq rev compress screw lck cap kit, 4.5 x 34mm - 320-20-34, s222422, eq rev compress screw lck cap kit, 4.5 x 42mm - 320-20-42, s117060, eq rev compress screw lck cap kit, 4.5 x 42mm - 320-20-42, 6287728.
Additional Manufacturer Narrative
(h3) the revision reported was likely the result of insufficient fixation between the implants and the bones and patient-related conditions, including multiple procedures/revisions on the involved shoulder, which led to aseptic (non-infected) humeral and glenoid loosening and subsequent compression screw fracture.However, this cannot be confirmed as the devices were not available for evaluation.Section h11: the following sections have corrected information: (h6) medical device problem code: 4002, loosening of implant not related to bone-ingrowth.

• Brand Name: EQUINOXE
• Common Device Name: REV COMPRESS SCREW LCK CAP KIT, 4.5 X 42MM
• 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: 13580978
• Report Number: 1038671-2022-00215
• Device Sequence Number: 4369051
• Product Code: KWT
• UDI-Device Identifier: 10885862086587
• UDI-Public: 10885862086587
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K063569
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2022

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: 320-20-42
• Device Catalogue Number: 320-20-42
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2022
• Supplement Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 08/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female