MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI 4 HOLE SHELL 58MM G; PROSTHESIS, HIP

Catalog Number 110010247

Device Problem Difficult or Delayed Separation (4044)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: item # 010002736/ g7 ball hex drvr for insr hndl/ lot # 062100.Item # 110003451/ g7 str modular shell inserter/ lot # 494810.Item # 110003452/ g7 str insrtr threaded shaft/ lot # 072082.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2022 -00195, 0001825034 -2022 -00199, and 0001825034 -2022 -00200.

Event Description

It was reported that during a hip procedure the cup insertion handle could not be loosened from cup.Tommy bar was used with g7 ball tip screw driver to try to release cup.G7 ball driver broke at tip and insertion handle was still attached to cup in patient.Whole construct was removed.No adverse events were reported.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g3; h2; h6 reported event was unable to be confirmed due to limited information provided by the customer.Dhr was unable to be reviewed as the lot number for the device is unknown.The root cause is 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

No additional event information to report at this time.

• Brand Name: G7 OSSEOTI 4 HOLE SHELL 58MM G
• 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: 13367847
• MDR Text Key: 287825145
• Report Number: 0001825034-2022-00197
• Device Sequence Number: 1
• Product Code: OQI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 110010247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 61 YR
• Patient Sex: Male