MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS SUTURE CUP, 39 (+2 LEFT); PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number UNIVERS REVERS SUTURE CUP, 39 (+2 LEFT)

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 09/16/2020

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 through the surgical outcome system that a issue possibly related to an arthrex product took place.Upon further investigation the following was discovered: a patient had undergone a reverse total shoulder arthroplasty (b)(6) 2019.It was diagnosed via x-ray and ct scan (b)(6) 2020 that the patient was experiencing loosening of the implant glenoid side.A revision of glenoid and humeral components with allograft surgery was performed (b)(6) 2020 during which time the following original arthrex implants were explanted: arthrex univers revers mgs peripheral screw nl 4.5x24 mm; lot #170182004; catalog # ar-9562-24nl.Arthrex univers revers mgs peripheral screw 4.5x32 mm; lot #2018001455; catalog # ar-9562-32nl; qty 2.Arthrex central screw modular 30 mm; lot #5652; catalog # ar-9561-30s.Arthrex glenosphere 39 +4 lat/24; lot #18.00656; catalog # ar-9564-2439-lat.Arthrex cup univers revs suture 39mm ntrl +2 left; lot #170074105; catalog # ar-9502f-39lcpc.Arthrex baseplate 24 m modular; lot #5362; catalog # ar-9560-24.After removal of the above devices the surgeon performed a conversion to hemiarthroplasty with glenoid bone graft.

• Brand Name: UNIVERS REVERS SUTURE CUP, 39 (+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: 10747417
• MDR Text Key: 213648759
• Report Number: 1220246-2020-02277
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00888867234239
• UDI-Public: 00888867234239
• 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: user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: UNIVERS REVERS SUTURE CUP, 39 (+2 LEFT)
• Device Catalogue Number: AR-9502F-39LCPC
• Device Lot Number: 170074105
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other