MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 FREEDOM CONST E1 LNR 36MM G; PROSTHETIC, 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	11/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the liner would not seat in the osseoti shell.A new shell was required to complete the procedure.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: mdr328146 and mdr328148.Item number: 00625006525, item name: bone scr 6.5x25 self-tap, lot #: j7222341; item number: 31-323230, item name: 3.2mmx30mm rnglc+ acet drl bit, lot #: 731380; item number: 00625006520, item name: bone scr 6.5x20 self-tap, lot #: j7278081; item number: 00625006530, item name: bone scr 6.5x30 self-tap, lot #: j7007847; item number: 00625006540, item name: bone scr 6.5x40 self-tap, lot #: j7332696; item number: 110010269, item name: g7 osseoti multihole 62mm h, lot #: 6902757; item number: 802403606, item name: zb 12/14 cocr frdm 36mm x +9, lot #: 3062343.Item number 00625006515 item name bone scr 6.5x15 self-tap lot # j6867004 item number 00625006515 item name bone scr 6.5x15 self-tap lot # j6993494 item number 00625006530 item name bone scr 6.5x30 self-tap lot # j6960420 item number 30253608 item name g7 vit e frdm const +5mm 36h lot # 65330653 the product has been received by zimmer biomet.The investigation is currently in process.Once the investigation has been completed, a follow-up report will be submitted.
Event or Problem Description
There is no update to the previous event description provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified both of the liners had damage to the locking feature.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the image provided was of the final implanted products.They did not enhance the investigation as the reported issue was to do with the returned components.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.

• Brand Name: G7 FREEDOM CONST E1 LNR 36MM G
• Common Device Name: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15833021
• Report Number: 0001825034-2022-02636
• Device Sequence Number: 17499556
• Product Code: PBI
• UDI-Device Identifier: 00880304989092
• UDI-Public: (01)00880304989092(17)260304(10)6982165
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2023

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: 03/04/2026
• Device Model Number: N/A
• Device Catalogue Number: 010000985
• Device Lot Number: 6982165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2022
• 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: 11/08/2022
• Supplement Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2021
• 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: Female