MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 FINNED 3 HOLE SHELL 50D; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 00625006530 ¿ bone screw ¿ j6829077.Reported event is unable to be confirmed due to limited information provided by the customer.Dhr was reviewed and no discrepancies were found.The root cause is 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.
Event or Problem Description
It was reported that during a hip procedure, the trilogy screw went all the way through the screw hole on the g7 shell.There was no reported harm or injury to the patient and the device remains implanted.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: G7 FINNED 3 HOLE SHELL 50D
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10850794
• Report Number: 0001825034-2020-04121
• Device Sequence Number: 16869825
• Product Code: LPH
• UDI-Device Identifier: 00880304672093
• UDI-Public: (01)00880304672093
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K142746
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/17/2020

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110017102
• Device Lot Number: 6756860
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1