MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL ARCOMXL LNR 36MM G; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: 110010268 ¿ g7 multihole shell ¿ 6908184.010000998 ¿ g7 screw ¿ 6871317.010000997 ¿ g7 screw ¿ 6874429.010001001 ¿ g7 screw ¿ 6847830.010000997 ¿ g7 screw ¿ 6932090.010000999 ¿ g7 screw ¿ 6936568.010000996 ¿ g7 screw ¿ 3716839.010000997 ¿ g7 screw ¿ 6874430.010000996 ¿ g7 screw ¿ 3839277.010000996 ¿ g7 screw ¿ 3215549.Product was returned to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during a hip procedure, the liner would not seat into the cup.A new liner was used to complete the surgery.There was no reported harm or injury to the patient.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g3; h2; h3; h4; h6 complaint sample was returned and evaluated against the reported event.Visual evaluation of product noted a shaving on the locking feature of the device.There is also black markings on the outside radius but no indentations.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
No additional event information to report at this time.

• Brand Name: G7 NEUTRAL ARCOMXL LNR 36MM G
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11739642
• Report Number: 0001825034-2021-01286
• Device Sequence Number: 19774399
• Product Code: PBI
• UDI-Device Identifier: 00880304524996
• UDI-Public: (01)00880304524996(17)240327(10)6515707
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2021

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 Expiration Date: 03/27/2024
• Device Model Number: N/A
• Device Catalogue Number: 010000742
• Device Lot Number: 6515707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 07/23/2021
• 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