MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RINGLOC+ REPLACEMENT RING SZ21; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Difficult to Insert (1316); Device Damaged by Another Device (2915); Material Twisted/Bent (2981)

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

Event Date 09/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of product returned.As per visual inspection, both the ring locks are bent.There is damage on the bearing and there are witness marks on the bearing from impacting into the lock ring.The tray is in perfect shape with no damage.Dhr was reviewed and no discrepancies were found.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

It was reported that during surgery, the humeral bearing was damaged when it was impacted during attempted assembly with the humeral tray.Due to this, the locking ring bent and did not allow the poly to engage.Surgery was completed with another device.No adverse events have been reported as a result of the malfunction.

• Brand Name: RINGLOC+ REPLACEMENT RING SZ21
• 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: 8292209
• MDR Text Key: 134593984
• Report Number: 0001825034-2019-00413
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 106021
• Device Lot Number: 058330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2018
• 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
• Treatment: 115370,COBALT CHROME STANDARD HUMERAL TRAY, 908890; XL-115364, HUMERAL BEARING, 155290
• Patient Age: 61 YR