MAUDE Adverse Event Report: UNIVERSAL GLENOID - BASEPLATE MEDIUM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	UNIVERSAL GLENOID - BASEPLATE MEDIUM
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Foreign Body In Patient (2687)
Date of Event	11/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that 6 years after the initial surgery, a revision surgery of the eclipse with the universal glenoid was necessary as the patient suffered pain in the shoulder joint.The sub-scapularis no longer had any function.Therefore an inverse prosthesis was indicated and a prosthesis 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 trunion.The lysis fringes are the result of the pe abrasion.Only small fragments of the pe insert were still present.Update 22-feb-2021: 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 : the revision surgery was performed on (b)(6) 2021.
Additional Manufacturer Narrative
Complaint not confirmed, however the heavy abrasion marks observed on the superior surface suggest the glenoid poly broke and the device may have been in contact with the humeral head.No other abnormality that may have contributed to the event were observed.

• Brand Name: UNIVERSAL GLENOID - BASEPLATE MEDIUM
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• MDR Report Key: 12506400
• Report Number: 1220246-2021-03671
• Device Sequence Number: 17120616
• Product Code: PHX
• UDI-Device Identifier: 00888867057357
• UDI-Public: 00888867057357
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2021

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: UNIVERSAL GLENOID - BASEPLATE MEDIUM
• Device Catalogue Number: AR-9120-02
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 11/02/2021
• 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