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

Model Number N/A

Device Problems Bent (1059); Device Damaged by Another Device (2915)

Patient Problem No Information (3190)

Event Date 03/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant products: ep-115393, e1 44-36 std hmrl brng, 963040; ep-115393, e1 44-36 std hmrl brng, 654320.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 02892, 0001825034 - 2018 - 02893.

Event Description

It was reported that the first humeral bearing was damaged during a back table assembly into the humeral tray.A new ring was put into the humeral tray.The second humeral bearing was also damaged during back table assembly.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the ring loc shows that it is bent and damaged.Dimensions taken on ring loc are conforming to specifications.Device history record 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.

• Brand Name: RINGLOC+ REPLACEMENT RING SZ21
• Type of Device: PROTHESIS, HIP
• 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: 7467734
• MDR Text Key: 106736406
• Report Number: 0001825034-2018-02891
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK070369
• 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,Followup
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 106021
• Device Lot Number: 039870
• Other Device ID Number: (01) 00880304355177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2017
• 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