MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 10 DEG ARCOMXL LINER 36MM D; PROSTHESIS - HIP

Catalog Number 010000778

Device Problem Fitting Problem (2183)

Patient Problem No Information (3190)

Event Date 10/07/2014

Event Type  malfunction  

Manufacturer Narrative

The product was received.Per results relayed by the engineer: the parts passed inspection of the outer profile.The scallop profile passed but the blend radii adjoining the scallop profile (feature f/25 on the drawing) was questionable.This may have been due to plastic deformation that occurred during impaction.A micrometer check of the f/31 diameter between the scallops (41.90 +/-.050) was performed.The diameter was checked in three places around the part with the results being 41.948, 45.945 and 45.947.All three measurements were within print specifications.Product likely left biomet control conforming.Review of device history records found these units were released to distribution with no deviations or anomalies.Review of complaint history found no additional issues for this part/lot.Relayed results to sales rep.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.This report is being submitted late as it has been identified in remediation.Zimmer biomet complaint: (b)(4).

Event Description

It was reported that during a total hip arthroplasty on (b)(6) 2014, the liner would not lock into the cup after several attempts.A g7 liner was used to complete the procedure.No further information has been provided.

• Brand Name: G7 10 DEG ARCOMXL LINER 36MM D
• Type of Device: PROSTHESIS - 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: 6990341
• MDR Text Key: 91197111
• Report Number: 0001822565-2017-07595
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 010000778
• Device Lot Number: 3143888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2013
• 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