MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HARD BEARING INST RING SZ C; PROSTHESIS HIP

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 02/26/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Complaint sample was evaluated and the reported event was confirmed.Visual inspection confirmed that the ring is fractured.The majority of the scratching and gouging on the inside and outside of the ring was observed near the fracture location.An isolated gouge was found on the rim.Device history record was reviewed and no discrepancies were found.Root cause was unable to 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 during a hip surgery, when the surgeon impacted the metal liner to the shell, the inserter ring was fractured.The line was fixed slightly diagonally.No adverse events have been reported as a result of the malfunction.

• Brand Name: G7 HARD BEARING INST RING SZ C
• 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: 8457662
• MDR Text Key: 140124230
• Report Number: 0001825034-2019-01426
• Device Sequence Number: 1
• Product Code: OQG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K150522
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• 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: 110026852
• Device Lot Number: 057660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1