MAUDE Adverse Event Report: ARTHREX, INC.; SHOULDR PROSTH, REVERSE CONFIG

Model Number 24MM BASEPLATE, 20° FULL AUG, +2 LAT, ST

Device Problems Break (1069); Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/03/2023

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 01/19/2024, a clindex notification was received indicating that a bone fracture in the target shoulder occurred to a patient listed on the shoulder arthroplasty registry.This event was initially indicated as probably related to the augmented baseplate, implanted on (b)(6) 2023, or the study the patient was part of.This resulted in medical or surgical intervention to prevent life-threatening illness, injury, or permanent impairment to the body structure or function.Additional information has been requested.

Event Description

Additional information was received on 1/19/2024: the patient was seen on (b)(6) 2024 for a fall and was given an x-ray.The x-ray revealed a scapular fx; the patient was scheduled for a ct before an appointment with dr.(b)(6).Dr.(b)(6) saw the patient on (b)(6) 2024, and surgery was discussed as a treatment for fracture as the patient is in significant pain.Surgery has been scheduled for (b)(6) 2024 for an orif procedure with the surgeon.Additional information received on 2/13/2024: the patient underwent revision surgery on (b)(6) 2024.The patient did not have any of the original arthrex products explanted during the revision surgery.The patient is still having pain post-operatively but has been instructed to continue post-op protocol.Products from another manufacturer were explanted.

Manufacturer Narrative

Additional information: b5, d4, g4, d11 concomitant devices with no allegation added here due to space limits in d11: ar-9564-2436-lat, lot: 22.04781, glen mgs 36mm +4.0 lat/24mm.Ar-9582-25, lot: 1356742235, post modular 25 mm.Ar-9502f-36lcpc,m lot: 22.02688, cup sut revs univs sz36 lt +2.Ar-9562-40nl, lot: 15036753, scr peri mgs 4.5x40mm.Ar-9563-16, lot: 15109617, scr peri lckg mgs 5.5mmx16mm.Ar-9562-28nl, lot: 15067438, scr peri mgs 4.5x28mm.Ar-9563-20, lot: 15107868, scr peri lckg mgs 5.5x20mm.Ar-9501-05p, lot: 22.04652 stem univ revers hum sz 5.Ar-9555-12, lot: 22.02373, spacr rev unvrs 36+12mm.Ar-9503s-03c, lot: 22.02916, ins hum s/36 + 3 fits 42cup cnst.B1: product problem changed to no, as of right now there is no allegation the device malfunctioned.B2: required intervention to prevent permanent impairment changed to yes.H6: medical device problem code changed to 3190.

• Brand Name: UNK
• Type of Device: SHOULDR PROSTH, REVERSE CONFIG
• 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: jared engle ; 8009337001
• MDR Report Key: 18678379
• MDR Text Key: 335030187
• Report Number: 1220246-2024-00890
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study,Health Professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24MM BASEPLATE, 20° FULL AUG, +2 LAT, ST
• Device Catalogue Number: AR-9580-2420-2S
• Device Lot Number: 1267942217
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention