MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS SUTURE CUP, 36 (NEUTRAL); PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number	UNIVERS REVERS SUTURE CUP, 36 (NEUTRAL)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091)
Date of Event	01/16/2020
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that a revision reverse total shoulder took place on (b)(6) 2020.The rep reported the revision procedure was due to a high suspicion of an infection, and the baseplate loosening.Prior to the revision procedure the patient was experiencing pain and swelling around the surgical site.X-rays were taken during a follow-up visit and revealed the loosened baseplate.Cultures were taken during the revision procedure and sent for testing.At this time an infection has not been confirmed.The primary and revision procedure were performed by the same surgeon and took place at the same facility.The rep reported at this time the date of the primary surgery, and full list of arthrex product implanted during the primary procedure is currently unknown.Additional information has been requested.The following arthrex parts were explanted during the revision procedure; ar-9503-3633-3 / lot: 18.00158 / qty.: 1, ar-9501-05p / lot: unknown / qty.: 1, ar-9555-06 / lot: 18.01505 / qty.: 1, ar-9502f-36cpc / lot: 18.00745 / qty.: 1, ar-9564-2433-lat / lot: 17.04762 / qty.: 1, ar-9563-16 / lot: 18.00182 //qty.: 1.An arthrex baseplate and screw were also removed.However, the part and lot numbers are currently unknown.

• Brand Name: UNIVERS REVERS SUTURE CUP, 36 (NEUTRAL)
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9659091
• Report Number: 1220246-2020-01639
• Device Sequence Number: 11676113
• Product Code: HSD
• UDI-Device Identifier: 00888867234192
• UDI-Public: 00888867234192
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K161782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/03/2020

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 Expiration Date: 07/31/2023
• Device Model Number: UNIVERS REVERS SUTURE CUP, 36 (NEUTRAL)
• Device Catalogue Number: AR-9502F-36CPC
• Device Lot Number: 18.00745
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 02/03/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other