MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 VIT E HIGH WALL LNR 40MM G; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/06/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported that during a hip procedure, the package was opened and the surgeon noticed a hair stuck to the implant.The product was removed and a new one was opened.There was no direct patient involvement.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was returned and reviewed against he reported event.Visual inspection found a loose hair like fiber that measures approximately 1 inch in length found on the inner spherical surface.Dhr was reviewed and no discrepancies were found.The root cause of the reported event is attributed to the operator not following instructions during manufacturing.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 additional event information to report at this time.

• Brand Name: G7 VIT E HIGH WALL LNR 40MM G
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10762860
• MDR Text Key: 213897845
• Report Number: 0001822565-2020-03678
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024520554
• UDI-Public: (01)00889024520554
• Combination Product (y/n): N
• PMA/PMN Number: K190660
• 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: 01/14/2021

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 Model Number: N/A
• Device Catalogue Number: 30124007
• Device Lot Number: 64843237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 10/30/2020
• Supplement Dates Manufacturer Received: 01/13/2021
• Supplement Dates FDA Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1