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

Model Number N/A

Device Problem Degraded (1153)

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

Event Date 05/19/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the threads on the trial gauge inserter are damaged, it will not screw on.No patient impact or delay in surgery.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No additional information on reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g4; h2; h3; h6 complaint sample was evaluated and the reported event was confirmed.Inspection of the returned device revealed shaving within the threads of the inserter.Assembled photos 1 and 2 show the ends of the shaving and the shaving wrapped around the tip.During the evaluation, the shaving was able to be unscrewed from the inserter tip.Visual inspection could not confirm if the shaving is part of the inserter or a mating device, although the shaving is likely from a different device.The threads of the inserter are deformed.The shaft is scratched and discolored consistent with a multiple use instrument.Impact marks were observed on the strike plate.Review of the device history records identified no deviations or anomalies during manufacturing.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.

• Brand Name: G7 STR MONOBLOCK SHELL INSRTR
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10147839
• MDR Text Key: 194944201
• Report Number: 0001825034-2020-02279
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304532694
• UDI-Public: (01)00880304532694
• 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
• Type of Report: Initial,Followup
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2020
• 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: 554480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1