MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS SUTURE CUP, 36 (+2 RIGHT); PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number UNIVERS REVERS SUTURE CUP, 36 (+2 RIGHT)

Device Problem Fracture (1260)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Implant Pain (4561)

Event Date 01/22/2021

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 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 Description

On 08/04/2022, it was reported by a patient via email that she underwent a reverse shoulder replacement on (b)(6) 2021, and is now experiencing sudden pain to her right shoulder when raising her arm overhead.X-rays suggest a stress fatigue fracture through the inferior screw.This demonstrates loosening of the left glenoshpere/baseplate.No additional information provided.Additional information requested.Additional information provided on 01/22/2021: implanted devices are as follows: right reverse tsr, arthrex univers 6mm stem with 36/+2 right suture cup, small 33/+3 humeral insert, 24mm mono-block base plate with 3 locking screws,+4/33mm glenophere.A ct scan of the right shoulder obtained at lehigh valley hospital is available for review.This demonstrates appropriate positioning of reverse tsr components.A minimal amount of fluid is seen.There is degenerative change to the ac joint.No lucency around the implants.Due to the artifact the screw fracture is not visible.At this time a revision surgery will not take place.Additional information requested.Additional information provided 09/21/2022: implanted devices are as follows: ar-9560-24p, batch 8164; ar-9502f-36rcpc, batch: 19.04738; ar-9564-2433-lat, batch: 19.00839; ar-9503-3633-3, batch: 19.02941; ar-9563-20, batch: 2019004605; ar-9563-32, batch: 2019004423; ar-9562-32nl, batch: 2019002834; ar-9501-06p, batch: 19.04248.It was reported by the patient that the revision took place on (b)(6) 2022.

• Brand Name: UNIVERS REVERS SUTURE CUP, 36 (+2 RIGHT)
• 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: 15575432
• MDR Text Key: 301547352
• Report Number: 1220246-2022-05582
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00888867234215
• UDI-Public: 00888867234215
• 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: Consumer
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• 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, 36 (+2 RIGHT)
• Device Catalogue Number: AR-9502F-36RCPC
• Device Lot Number: 19.04738
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2022
• Date Device Manufactured: 04/01/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other