MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +10; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-10-10

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 08/22/2023

Event Type  Injury  

Manufacturer Narrative

Section h10: (h3) pending evaluation.(d10) concomitant device(s): (b)(6), 308-02-09 - 9x120mm distal stem modular cemented; (b)(6), 308-05-33 - distal fixation ring ha 33.5; (b)(6), 308-10-05 - large prox body +0; (b)(6), 308-15-01 - taper locking screw 0; (b)(6), 320-10-10 - equinoxe reverse tray adapter plate tray +10; (b)(6), 320-20-00 - eq reverse torque defining screw kit; (b)(6), 320-42-00 - 145-deg pe 42mm hum liner +0; (b)(6), 320-42-03 - 145-deg pe 42mm hum liner +2.5; (b)(6), tpa-13 - cement restrictor xs (extra small, sz 13).

Event Description

As reported, this 64 year old male patient¿s right shoulder was initially was implanted with an competitor shoulder.The patient¿s shoulder was chronically dislocating and was scheduled for a revision of the humeral implants to exactech hrp implants due to proximal bone loss as well.The hrp procedure was performed on (b)(6) 2023 where the surgeon implanted hrp implants, kept the competitor glenoid implants, and matched the competitor glenosphere size to the exactech tray and liner corresponding size.Within two weeks post-operation of the hrp procedure on (b)(6) the patient dislocated their hrp reverse again while being hospitalized for an extended period of time.Due to the continued chronic dislocation of a reverse tsa revision implant, the surgeon scheduled the patient for a revision of the reverse hrp to a hemi hrp.The revision hrp reverse to hemi was performed on (b)(6) 23.The patient was revised from the competitor¿s glenoid and this manufacturer¿s reverse tray and liner to an increased length proximal body, 0mm replicator plate, and a 53x28mm humeral head.No glenoid implant was used, and the patient received a hemi shoulder hrp arthroplasty.The patient required prolonged hospitalization due to these issues.Devices not available for return.

• Brand Name: EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +10
• 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: 17765101
• MDR Text Key: 323617903
• Report Number: 1038671-2023-02293
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086433
• UDI-Public: 10885862086433
• 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: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-10-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/04/2016
• 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: SEE H10
• Patient Age: 64 YR
• Patient Sex: Male