MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL E1 LINER 28MM C; HIP PROSTHESIS

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant products: 010000798 g7 hi-wall arcomxl lnr 28mm c 3125064; 110010242 g7 osseoti 3 hole shell 48mm c 6186644 ; 0106010002 avenirâ® mã¼ller, stem, standard, uncemented, ha, 2, taper 12/14 2923036; 00877502801 bioloxâ® delta, ceramic femoral head, s, 㸠28/-3.5, taper 12/14 2916701; 00625006540 bone screw self-tapping 6.5 mm dia.40 mm length 63980985.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned liner shows damage from attempted implantation and removal confirming the complaint.The inner and outer spherical radius exhibit gouges.The indentations found on the outer radius and the severely deformed polyethylene scallops indicate the liner may not have been properly aligned with the recessed areas on the shell at the time of impaction.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.The liner not fully seating in the shell prior to impaction, likely contributed to the reported condition; however with the information provided, a specific cause could not 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.

Event Description

It was reported that the patient had a high bmi(body mass index) and liner would not seat in cup.Associate ran to get another liner and open it, took maybe 5 extra minutes.In that time he got some osteophytes from around the cup and the other liner sat down on the first try.

• Brand Name: G7 HI-WALL E1 LINER 28MM C
• Type of Device: HIP PROSTHESIS
• 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: 7480835
• MDR Text Key: 107201337
• Report Number: 0001825034-2018-03155
• 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: Physician
• Type of Report: Initial
• Report Date: 05/02/2018

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 Expiration Date: 07/10/2020
• Device Model Number: N/A
• Device Catalogue Number: 010000915
• Device Lot Number: 3606646
• Other Device ID Number: (01)00880304526921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2018
• Initial Date FDA Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2015
• 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
• Patient Age: 71 YR