MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING ARCOMXL; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Mechanical Problem (1384)

Patient Problem No Information (3190)

Event Date 01/05/2017

Event Type  malfunction  

Manufacturer Narrative

Pt identifier: - (b)(6).Udi #: (b)(4).Concomitant medical product: ringloc + replacement ring size 21, catalog#: 106021, lot#: 194150.Comprehensive reverse shoulder humeral tray with locking ring, catalog#: 115370, lot#: 163750.Comprehensive reverse shoulder glenosphere, catalog #: 115310, lot #:296010.Comprehensive reverse baseplate + adapter, catalog #: 010000589, lot #: 305540.Comprehensive mini humeral stem, catalog #: 113631, lot #: 894140.Palacos cement, catalog #: 00-1113-140-01, lot #: 83194475.Comprehensive reverse central screw, catalog #: 115395, lot #: 485030.Comprehensive fixed locking screw, catalog #: 180551, lot # 358330 (qty 2).Comprehensive fixed locking screw, catalog #: 180551, lot #: 358350.Comprehensive fixed locking screw, catalog #:180550, lot #: 280260.Comprehensive central screw drill bit, catalog #: 405883, lot #: 442530.Humeral bearing assembly tool, catalog#: 110017268, lot#: ni.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action(s) is/are required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-00291, 00292.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

It is reported that during a reverse shoulder procedure, the locking ring did not continue to wiggle after the bearing was inserted.A new tray and bearing were unavailable, so the locking ring was replaced with a replacement locking ring of the same size that experienced the same issue.This second ring was used to complete the procedure due to lack of other options.The surgeon does not know if this will cause future issues.

• Brand Name: COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING ARCOMXL
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6615580
• MDR Text Key: 76832186
• Report Number: 0001825034-2017-03633
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/22/2021
• Device Model Number: N/A
• Device Catalogue Number: XL-115363
• Device Lot Number: 488870
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2016
• 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: 79 YR