MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 STR MONOBLOCK SHELL INSRTR; INSTRUMENT

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Manufacturer Narrative

The product was returned for evaluation and based on the investigation the complaint was not confirmed.Based on dhrs, the product was made to print and correct materials.Product left conforming to print as there was no evidence that states otherwise.The inserter had a very minor dent on the first lead thread, which wouldn¿t affect the function of the inserter and there isn¿t any appearance of a fracture as stated in the complaint.Review of complaint history identified an issue that was addressed in internal controls.A summary of the investigation has been sent to the complainant.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation, under precautions: ¿intraoperative fracture or breaking of instruments has been reported.Surgical instruments are subject to wear with normal usage.¿ following review, no new risks were identified.(b)(6).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 an initial total hip arthroplasty on an unknown date, the impactor threads that attach to the cup were damaged.

• Brand Name: G7 STR MONOBLOCK SHELL INSRTR
• Type of Device: INSTRUMENT
• 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: 6955874
• MDR Text Key: 90522049
• Report Number: 0001825034-2017-08961
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• 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: 110003450
• Device Lot Number: 375770
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2014
• 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