MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 VIT E NEUTRAL LNR 36MM G; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

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

Event Date 08/21/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during an hip arthroplasty, the surgeon complained liner would not seat in cup.He impacted the liner but said it wasn't close to being engaged and thought the liner was too small for the cup.No further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Updated: b4, b5, d10, g4, h2, h3, h6 complaint sample was evaluated and the reported event was not confirmed.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.A g7 vivacit-e netural liner was returned.Visual evaluation identified no damage.Device measurement cannot be performed as product was impacted and will affect measurement accuracy.No further evaluation could be performed with the returned product.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

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

• Brand Name: G7 VIT E NEUTRAL LNR 36MM G
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10464812
• MDR Text Key: 204698972
• Report Number: 0001825034-2020-03396
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024519923
• UDI-Public: 00889024519923
• 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: 09/08/2020

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: 30103607
• Device Lot Number: 64358595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/21/2020
• Initial Date FDA Received: 08/28/2020
• Supplement Dates Manufacturer Received: 09/02/2020
• Supplement Dates FDA Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1