MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 ACETABULAR LINER ARCOMXL HIGHLY CROSSLINKED UHMWPE; HIP PROSTHESIS

Model Number N/A

Device Problems Detachment Of Device Component (1104); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 11/22/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that patient had a squeaking sound in their hip two days post-implantation.Subsequently, the patient was revised approximately one month post-implantation due to disassociation of the liner from the cup.The head, liner, and cup were removed and replaced.

Manufacturer Narrative

Concomitant medical products: 110010245 g7 osseoti 4 hole shell 54mm f 3848754 unknown stem, 010000999 g7 screw 6.5mm x 30mm 3666640.Reported event was confirmed by review of x-rays provided.The x-ray report confirms that liner was disassociated from the cup.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

Manufacturer Narrative

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.

• Brand Name: G7 ACETABULAR LINER ARCOMXL HIGHLY CROSSLINKED UHMWPE
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6190684
• MDR Text Key: 62906501
• Report Number: 0001825034-2016-05253
• Device Sequence Number: 1
• Product Code: JDI
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 010000786
• Device Lot Number: 3593242
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2016
• Initial Date FDA Received: 12/20/2016
• Supplement Dates Manufacturer Received: 03/02/2018; 03/07/2018
• Supplement Dates FDA Received: 03/06/2018; 03/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR