MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 54F; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2023
Type of Reportable Event	Malfunction
Additional 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.Multiple mdr reports were filed for this event, please see associated report: 0001825034-2023-00550.
Event or Problem Description
It was reported that during a right hip procedure the shell got stuck on the inserter handle, and surgeon could not separate them.Another handle and shell were used to complete the case.There was no consequences or impact to the patient.No additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Product was returned and evaluated.A visual examination of the returned product identified that the shell and inserter were disassembled upon receipt.The inserter shaft was scratched.The threads of the inserter were free of significant damage.Dark debris was present within the threads.The shell exhibited similar debris within the threads.No thread damage was observed on the shell.During evaluation, the shell was able to be threaded onto and off of the inserter multiple times.The shell fully engages the inserter threads.Medical records were not provided.The reported products were reviewed for compatibility with no issues noted.A review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.No device problem was found.The devices function as intended.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 further event information is available at the time of this report.

• Brand Name: G7 PPS LTD ACET SHELL 54F
• Common Device Name: PROSTHESIS, 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: 16645933
• Report Number: 0001825034-2023-00549
• Device Sequence Number: 12274096
• Product Code: PBI
• UDI-Device Identifier: 00880304524231
• UDI-Public: (01)00880304524231(17)321027(10)7370053
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2023

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 Model Number: N/A
• Device Catalogue Number: 010000664
• Device Lot Number: 7370053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2023
• 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: 03/10/2023
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 04/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2022
• 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