MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	+5 EXTRA LAT LEFT TRAY
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	06/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 75 yo male patient who was enrolled in an exactech shoulder clinical study on (b)(6) 2022, received exactech devices on (b)(6) 2022, after their antibiotic spacer was removed and the shoulder was irrigated and debrided.Date of initial exactech device(s)implantation, and placement of the antibiotic spacer unknown.They were revised on (b)(6) 2022, due to infection and dislocation of their replacement.Date of onset, (b)(6) 2022.The surveillance cultures tested positive for staph epidermidis.After consultation with infection disease, he was placed on doxycycline.X-rays showed anterior dislocation of replacement, there also appeared to be displacement of bony fragment of the calcar region.The tray, liner, glenosphere, and glenosphere screws were revised.The patient¿s outcome was last known as resolved.The case report form indicates this event is possibly related to device and possibly related to procedure.Devices will not be returned.No further information known.
Additional Manufacturer Narrative
D2b: prosthesis, shoulder, non-constrained, metal/polymer cemented.D10: concomitants: humeral stem or stemless 300-01-15.Reverse humeral liner 320-42-03.Reverse humeral tray (extension) 320-20-01.Reverse glenosphere 320-08-42.Reverse glenosphere baseplate 320-15-01.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H3: based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.

• Brand Name: EQUINOXE
• 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 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17808356
• Report Number: 1038671-2023-02010
• Device Sequence Number: 6691729
• Product Code: KWS
• UDI-Device Identifier: 10885862567772
• UDI-Public: 10885862567772
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K191561
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2024

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: +5 EXTRA LAT LEFT TRAY
• Device Catalogue Number: 320-05-21
• 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: 08/02/2023
• Supplement Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2021
• 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: Other; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White