MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 FINNED 4 HOLE SHELL 62H; PROSTHESIS HIP

Catalog Number 110017108

Device Problem Material Deformation (2976)

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

Event Date 04/08/2021

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 that during a surgery when preparing the cup for insertion, during the removal of the screw hole covers, two of them were stuck and subsequently stripped in the cup.The cup was removed and a new one was inserted without incident.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g3; e1; h2; h3; h6.A g7 finned 4 hole shell 62h, part # 110017108 from lot 3656773, was returned and evaluated against the complaint.Visual inspection confirmed that 2 screw hole plugs have been removed while 2 remain in place.The hex features were engaged with lab hex driver, part number 110003330, lot 054007) the driver is only able to engage the hex feature at the bottom of the hole.The driver slips out of the hex feature as light rotational force is applied to the driver.All other surfaces of the shell are free of any visible damage.Device history record (dhr) was reviewed and no discrepancies were found.The root cause of the reported issue is attributed to a manufacturing deficiency.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 FINNED 4 HOLE SHELL 62H
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11766142
• MDR Text Key: 248813489
• Report Number: 0001825034-2021-01300
• Device Sequence Number: 1
• Product Code: OQG
• UDI-Device Identifier: 00880304672154
• UDI-Public: (01)00880304672154(17)251021(10)3656773
• Combination Product (y/n): N
• PMA/PMN Number: K142746
• 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

• Date FDA Received: 05/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 110017108
• Device Lot Number: 3656773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1