MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GLENOSPHERE IMPACTOR HEAD; ORTHOPAEDIC IMPLANT IMPACTOR

Catalog Number 00430903112

Device Problem Fracture (1260)

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

Event Date 08/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device name: phx.Product has been received by zimmer biomet.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the bf reverse shoulder impactor head fractured into two pieces when used to seat the 36mm glenosphere.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No further event information is available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, g4, g7, h2, h3, h6, h10.D4: (b)(4).Visual examination of the returned product identified the item is fractured.Dimensions taken are within spec.Item and lot numbers verified.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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: GLENOSPHERE IMPACTOR HEAD
• Type of Device: ORTHOPAEDIC IMPLANT IMPACTOR
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10477198
• MDR Text Key: 206385009
• Report Number: 0001822565-2020-03050
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• PMA/PMN Number: K052906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00430903112
• Device Lot Number: 61971228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/20/2020
• Initial Date FDA Received: 09/01/2020
• Supplement Dates Manufacturer Received: 01/07/2021
• Supplement Dates FDA Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1