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

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 04/28/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-01514.

Event Description

It was reported that threaded tip on inserter broke off in the 32mm impactor when surgeon was impacting liner.All parts were retrieved.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; h3; h6.   one g7 str monoblock shell insrtr was returned and evaluated.Upon visual inspection the ball impactor has a square indentation on the od of the device and there are fractured threads inside the threaded portion of the device.The returned inserter has impact marks on the strike plate and some scuffing on the shaft.The threaded tip of the device had fractured from the device.A review of the device history records identified deviations or anomalies during manufacturing, the deviations or anomalies would not have attributed to the event.Medical records were not provided.A definitive root cause cannot 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 further event information available at the time of this report.

• Brand Name: G7 STR MONOBLOCK SHELL INSRTR
• Type of Device: INSTRUMENT, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11847716
• MDR Text Key: 251379566
• Report Number: 0001825034-2021-01513
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304532694
• UDI-Public: (01)00880304532694(11)150911(10)252270
• Combination Product (y/n): N
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 252270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/04/2021
• Initial Date FDA Received: 05/19/2021
• Supplement Dates Manufacturer Received: 09/07/2021
• Supplement Dates FDA Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1