MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 LONGEVITY HIGH WALL 40MM F; 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	05/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 110010265 ¿ g7 shell ¿ 65202253.12-151307 ¿ echo stem ¿ 209510.010001035 ¿ cocr head ¿ j7181153.Reported event was unable to be confirmed due to limited information provided by the customer.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 or Problem Description
It was reported that during a left hip procedure, the liner would not seat in the cup.The surgeon hit so hard during attempts to seat the liner that the cup dislodged.The surgeon had to implant a larger cup and liner as a result.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.

• Brand Name: G7 LONGEVITY HIGH WALL 40MM F
• Common Device Name: 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: 14427980
• Report Number: 0001822565-2022-01451
• Device Sequence Number: 20205713
• Product Code: LPH
• UDI-Device Identifier: 00889024519381
• UDI-Public: (01)00889024519381(17)261005(10)65233858
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K190660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/16/2022

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: 10/05/2026
• Device Model Number: N/A
• Device Catalogue Number: 20124006
• Device Lot Number: 65233858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2022
• Initial Report FDA Received Date: 05/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Patient Sex: Male