MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE ARCOM XL 44-36 STANDARD HUMERAL BEARING; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Unintended System Motion (1430)

Patient Problem Tissue Damage (2104)

Event Date 02/26/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: comprehensive reverse shoulder humeral tray with locking ring 44 mm standard ;[catalog # 115340; lot 659950]; glenoid baseplate [catalog # 115330; lot 863590]; arcomxl standard humeral bearing 44 ¿ 36 mm [catalog # xl-115363; lot 745250]; versa-dial glenosphere standard 36 mm [catalog # 115310; lot 457000]; humeral stem standard 10 mm [catalog # 113650; lot 623850]; fixed non-locking screw 4.75 3.5 hex 15 mm [catalog # 180507; lot 852390]; fixed locking screw 4.75 mm 3.5 hex 20 mm [catalog # 180501; lot 851510] ; fixed locking screw 4.75 mm x 15 mm [catalog # 180500; lot 468560]; fixed locking screw 4.75 mm 3.5 hex 15 mm [catalog # 180500; lot 851320]; central screw 6.5 3.5 hex 25 mm [catalog # 115381; lot 320020]; versa-dial taper adaptor [catalog # 118001; lot 380360].The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Remains implanted.

Event Description

It was reported that a patient underwent a total reverse shoulder arthroplasty.Subsequently, the patient went in for a humeral fracture repair.During this procedure, the surgeon checked the glenosphere for loosening due to large amounts of inferior scapular notching.The surgeon found the glenosphere to be stable, however, the inferior screw was compromised.Due to the stability of the remaining screws, no devices were revised.No further information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed with operative notes received from the customer.Dhr was reviewed with no related manufacturing deviations or anomalies identified.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further information available.

• Brand Name: COMPREHENSIVE ARCOM XL 44-36 STANDARD HUMERAL BEARING
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7779347
• MDR Text Key: 116996002
• Report Number: 0001825034-2018-05128
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Model Number: N/A
• Device Catalogue Number: XL-115363
• Device Lot Number: 745250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR