MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOM XL 44-36 STD HMRL BRNG; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Difficult to Insert (1316); Difficult To Position (1467); Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/22/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was not confirmed.Per indicated that after reviewing the procedure with the sales representative present during the occurrence was unable to pin point when the ring became hung-up in the tray.At some point after shipment accidental mechanical damaged occurred.The dimensional sheet found all mating features within specification.The dimensions were taken where mechanical damaged had not occurred.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to customer preference.Completion of investigation relayed to sales rep via email.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation: under section 3.1.1: "humeral bearing does not assemble to humeral tray." 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.Multiple mdr reports were filed for this event, please see associated reports: 1825034 ¿ 2017 ¿ 07923 / 07939 / 07940.

Event Description

It was reported that during an initial reverse shoulder arthroplasty on (b)(6) 2015, while attempting to put the bearing in place, bearing was flush with the tray, however, the locking ring would not lock.Another locking ring was used with the same results, the surgeon then tried using a different poly but again, the same thing happened.The surgeon completed the procedure with a +5 tray and a +3 bearing.No additional patient consequences were reported.Attempts have been made and no further information has been provided.

• Brand Name: ARCOM XL 44-36 STD HMRL BRNG
• 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: 6915599
• MDR Text Key: 88469041
• Report Number: 0001825034-2017-07938
• Device Sequence Number: 1
• Product Code: PAO
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2020
• Device Model Number: N/A
• Device Catalogue Number: XL-115363
• Device Lot Number: 713900
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2015
• 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 Age: 69 YR