MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI 4 HOLE SHELL 60MM G; PROSTHESIS, HIP

Model Number N/A

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2020

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.Concomitant medical products: 110003452, g7 str insrtr threaded shaft, lot number unknown, 010002736, g7 ball hex drvr for insr hndl, lot number 061706, 110003451, g7 str modular shell inserter, lot number 253370, multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01274, 0001825034-2020-01277.

Event Description

It was reported that the scrub tech unknowingly cross threaded the g7 straight inserter onto the g7 cup during initial tha.Upon impacting the cup into the acetabulum, the inserter became cold welded to the g7 cup.Inserter screwdriver ball tip broke off while trying to disengage inserter from cup.Case was converted to the continuum acetabular system with no impact to the surgeon or the patient.It was reported that no further information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d4; d11; h2; h3; h4; h6 d11: 110003452, g7 str insrtr threaded shaft, lot number 061289 010002736, g7 ball hex drvr for insr hndl, lot number 061706 110003451, g7 str modular shell inserter, lot number 253370 reported event was unable to be confirmed.Device was returned and evaluated against the complaint.Upon receipt, the shell was disassembled from the inserter.No notable damage was observed to the shell or its threads.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.

Event Description

No further event information available at the time of this report.

• Brand Name: G7 OSSEOTI 4 HOLE SHELL 60MM G
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9879992
• MDR Text Key: 185907332
• Report Number: 0001825034-2020-01275
• Device Sequence Number: 1
• Product Code: OQI
• Combination Product (y/n): N
• PMA/PMN Number: K140669
• 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: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• 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: 110010248
• Device Lot Number: 6665675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1