MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 FINNED 3 HOLE SHELL 52E; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Deformation (2976); Physical Resistance/Sticking (4012)

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

Event Date 07/28/2021

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 the scrub tech and surgeon were unsuccessful in removing the screw cap cover from the acetabular shell causing the hex to strip out.No adverse consequences were reported.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: b4, b5, d4, g3, g6, h2, h3, h4, h6, h10 the event was confirmed with product received.A g7 finned 3 hole shell 52e, part # 110017103 from lot 7001244, was returned and evaluated against the complaint.Visual inspection found the hex feature of the remaining screw plug to be stripped.The apical plug was also returned but exhibits no signs of damage or stripping.A small scratch was observed near the center screw plug hole but the shell is in good overall condition.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was 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.

• Brand Name: G7 FINNED 3 HOLE SHELL 52E
• 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: 12301878
• MDR Text Key: 265841630
• Report Number: 0001825034-2021-02353
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142746
• 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: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• 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: 110017103
• Device Lot Number: 7001244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2021
• 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 Sex: Female