MAUDE Adverse Event Report: ARTHREX, INC. UNI GLENOID-PERIPHERAL LOCK SCRW; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	UNI GLENOID-PERIPHERAL LOCK SCRW
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint not confirmed, no abnormalities were observed that may have contributed to the event.The drive feature damage is likely a result of the implantation and/or removal process.
Event or Problem Description
It was reported that 6 years after the initial surgery in the (b)(6) a revision surgery of the eclips with the universal glenoid was necessary as the patient suffered pain in the shoulder joint.The subscapularis no longer had any function.Therefore an inverse prosthesis was indicated and a prothesis from another manufacturer was implanted.As the patient was allergic to metal no modular conversion of the glenoid could be performed.Therefore the universal glenoid and the eclipse had to be removed.The surgeon further reported that dark traces were identified below the trunnion.Theses lysis fringes are the result of the pe abrasion.Only small fragments of the pe insert were still present.Update 22-feb-2021 dw.X-ray pictures and a surgery report was provided with the information that the initial surgery was performed on (b)(6) 2017.The reported event was identified on (b)(6) 2020 via scintigraphy.Update 26-feb-2021 dw.The revision surgery was performed on (b)(6) 2021.Update 01-sep-2021 dw.Additional devices were returned and added to the case.Update 25-oct-2021 dw.During the evaluation an additional affected lot was identified and therefore added to the case.

• Brand Name: UNI GLENOID-PERIPHERAL LOCK SCRW
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 12814146
• Report Number: 1220246-2021-03918
• Device Sequence Number: 11988462
• Product Code: PHX
• UDI-Device Identifier: 00888867057722
• UDI-Public: 00888867057722
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K142863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/15/2021

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: UNI GLENOID-PERIPHERAL LOCK SCRW
• Device Catalogue Number: AR-9145-30
• Device Lot Number: 15.00439
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown