MAUDE Adverse Event Report: ZIMMER BIOMET, INC. IMPACTOR FOR ACETABULAR CUP

Model Number N/A

Device Problems Device Abrasion From Instrument Or Another Object (1387); Naturally Worn (2988)

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

Event Date 02/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned product showed small hairline cracks can be observed on the top of the cap near the threaded screw hole.Signs of wear were observed on the impactor insert.Metal particulates are embedded in the surface of the cap.Dimensional readings are conforming to print 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.

Event Description

It was reported that there is metal residue embedded in the acetabular shell impactor and the customer is requesting a replacement.No adverse events have been reported as a result of the malfunction.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.Updated: it was identified an internal software error produced and submitted an invalid device product code in the previous submissions related to this reporting.The device product code has been updated with no further changes.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.

• Brand Name: IMPACTOR FOR ACETABULAR CUP
• 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: 7444449
• MDR Text Key: 106033642
• Report Number: 0001822565-2018-02285
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00151603044
• Device Lot Number: 62989802
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/23/2018
• Initial Date FDA Received: 04/19/2018
• Supplement Dates Manufacturer Received: 12/12/2018
• Supplement Dates FDA Received: 12/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1