MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 CURVED ACET SHELL INSERTER; PROSTHESIS, HIP

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395); Unstable (1667)

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

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation due to unknown product location.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Complaint history was performed and there were no issues reported for this item.The complaint was not confirmed and root cause could not be determined.Risks associated with reported condition are addressed through the warnings in the package insert as a part of design control risk management.There are warnings in the package insert, under care and handling of instruments, number 1 states, "surgical instruments and instrument cases are susceptible to damage for a variety of reasons including prolonged use, misuse, rough or improper handling.Care must be taken to avoid compromising their exacting performance." following review, no new risks were identified.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.Zimmer biomet complaint (b)(4).Product location unknown.

Event Description

It was reported that during a total hip procedure on an unknown date, the surgeon had difficulty with the instrument being loose as if it were disengaging.There was no patient injury or delay in the procedure reported.Attempts have been made and no further information has been provided.

• Brand Name: G7 CURVED ACET SHELL INSERTER
• 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: 6915445
• MDR Text Key: 88230155
• Report Number: 0001825034-2017-07873
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• 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: 110003453
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1