MAUDE Adverse Event Report: ARTHREX, INC. UNIVERSAL GLENOID - BASEPLATE SMALL; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number UNIVERSAL GLENOID - BASEPLATE SMALL

Device Problem Break (1069)

Patient Problems Fall (1848); Device Embedded In Tissue or Plaque (3165)

Event Date 03/20/2020

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.

Event Description

It was reported that on (b)(6) 2019 a revers shoulder arthroplasty was performed.Everything went well and it was finished successfully.The surgeon was satisfied after the case.This was also showed on the x-rays.Approximately 6 months post-op the patient reported subsequently failing while putting on trousers.He felt an issue.This was when the glenoid side gave way.It was an elective revers and not a fracture revers.X-rays were done on (b)(6) 2020.A revision surgery is planned to be on (b)(6) 2020.Update 02-apr-2020: further information was received: the revision surgery went ahead on (b)(6) 2020 afternoon.It was revised with the new modular glenoid system, successfully using an iliac crest graft.Everything went very well.The failed devices were retrieved, however both peripheral screws were broken and the tips remain in the patient.Baseplate, central screw & remaining portion of peripheral screws x 2 will be returned assembled.Also from the humeral side the cup and liner, which needed to be removed for access, will be returned.There was no issue with the humeral side, however they will be returned regardless.

Event Description

Follow-up update on 29-apr-2020 : further information was provided that the patient was elderly and the bone quality was not in top condition but also not too bad.The damage to the implants occurred (as the patient claims) when putting on trousers, this necessitated the revision, they did not break on removal, they were already broken from whatever trauma they suffered.It was further reported that it is very unlikely that just putting on trousers caused both screws to break.

Manufacturer Narrative

Complaint not confirmed, no abnormality was observed on the device that may have contributed to the event.Additional information provided has been added to section b.

• Brand Name: UNIVERSAL GLENOID - BASEPLATE SMALL
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9985350
• MDR Text Key: 188480381
• Report Number: 1220246-2020-01797
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867057340
• UDI-Public: 00888867057340
• Combination Product (y/n): N
• PMA/PMN Number: K142863
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: UNIVERSAL GLENOID - BASEPLATE SMALL
• Device Catalogue Number: AR-9120-01
• Device Lot Number: 18.01824
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/26/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other