MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS SUTURE CUP, 42 (+2 LEFT); PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number UNIVERS REVERS SUTURE CUP, 42 (+2 LEFT)

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atrial Fibrillation (1729); Hematoma (1884); Failure of Implant (1924); Tissue Breakdown (2681)

Event Date 11/19/2019

Event Type  Injury  

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 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 (b)(6) 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 SUTURE CUP, 42 (+2 LEFT)
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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: 9506061
• MDR Text Key: 185782451
• Report Number: 1220246-2019-01512
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00888867234260
• UDI-Public: 00888867234260
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161782
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNIVERS REVERS SUTURE CUP, 42 (+2 LEFT)
• Device Catalogue Number: AR-9502F-42LCPC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR