MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL ARCOMXL LNR 36MM D; PROSTHESIS, HIP

Model Number N/A

Device Problems Difficult to Insert (1316); Difficult To Position (1467); Fitting Problem (2183)

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

Event Date 07/22/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual inspection showed deformation present in the scallop area of the returned liner.The liner was checked on an overlay for outer geometry.The part checked good outside of the areas that deformation was present.It should be noted that plastic deformation can occur easily when polyethylene liners are impacted in an attempt to lock them into place.In addition the scallop profile was checked using the co-ordinate measuring machines (cmm) and showed similar deformation.It is probable that this plastic deformation is responsible for the deformations noted.A micrometer check of the f/31 diameter between the scallops (41.90 +/-.050) was performed and met specification.Outside of the deformation all features measured as part of the investigation were to print specifications.Manufacturing history record (mhr) was reviewed and no discrepancies were found.Root cause was determined cannot be determined with the provided information.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation: under 4.2.1 - risk of components not fitting together in item.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 during a total hip arthroplasty on (b)(6) 2015, the surgeon could not get the high wall liner to seat into the cup on multiple attempts.A new liner was provided and worked immediately.No further information has been provided.

• Brand Name: G7 HI-WALL ARCOMXL LNR 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: 6934207
• MDR Text Key: 90042058
• Report Number: 0001825034-2017-08310
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2019
• Device Model Number: N/A
• Device Catalogue Number: 010000817
• Device Lot Number: 3378317
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2014
• 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