MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS APEX STEM, SIZE 7; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	UNIVERS REVERS APEX STEM, SIZE 7
Health Effect - Clinical Codes	Anemia (1706); Atrial Fibrillation (1729); Hematoma (1884); Tissue Breakdown (2681)
Date of Event	11/19/2019
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 device remains in the patient.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 via the surgical outcome system that a patient was having complications possibly related to a prior implanted arthrex product.Complications mentioned were hematoma.Additional information obtained 12/3/2019: the surgeon's representative has confirmed that a patient had an initial prior rotator cuff repair and required a second left reverse shoulder arthroplasty on (b)(6) 2019.The operative report from 11/13/2019 noted that three metal corkscrew anchors had been explanted prior to proceeding with the procedure.During the procedure the following arthrex products were implanted: ar-9564-2442-lat (modular glenosphere), ar-9501-07s (humeral stem) and ar-9502f-42lcpc (suture cup).On (b)(6) 2019 the patient was admitted to the hospital urgently after his large hematoma began to have wound breakdown and he had anemia with symptomatic atrial fibrillation with rvr.Surgeon admitted the patient for surgical exploration with evacuation of hematoma, debridement, exploration of tendon transfer site and administration of local antibiotics.Operative report noted there was no evidence of infection and the subscapularis repair and the tendon transfer repair were intact.The prosthesis was also located and appeared in good position.The prosthesis implanted on (b)(6) 2019 were not explanted during the (b)(6) 2019 procedure.Additional information obtained 12/6/19: the surgeon's office has confirmed that the patient's original rotator cuff procedure was approximately 15 years prior and was performed by a different surgeon in a completely different area of the state.There is no additional information known regarding this original procedure or any implants that may have been used at that time.

• Brand Name: UNIVERS REVERS APEX STEM, SIZE 7
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9506047
• Report Number: 1220246-2019-01511
• Device Sequence Number: 13779290
• Product Code: PHX
• UDI-Device Identifier: 00888867250482
• UDI-Public: 00888867250482
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K170414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/20/2019

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: UNIVERS REVERS APEX STEM, SIZE 7
• Device Catalogue Number: AR-9501-07S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 12/20/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR