MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 62H; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Codes	Material Deformation (2976); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign: canada.Visual evaluation of the provided photos and returned product found black porous coating debris in the damaged pouch.Further evaluation of the damaged pouch found sterility has been breached.Additionally, an unknown metal piece was retrieved from the returned packaging.As the packaging was previously opened, it cannot be determined where the unknown metal piece came from; however, manufacturing has been ruled out.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.The condition of the device when it left zimmer biomet control is considered conforming to specification.The root cause of the reported event (damaged pouch and black porous coating debris) can be attributed to transit damage.The root cause of the reported event (unknown metal piece) cannot be determined with the information provided.This complaint (damaged pouch and black porous coating debris) was confirmed by evaluation of the provided photos and returned product.The complaint for the unknown metal piece cannot be confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor trends.
Event or Problem Description
It was reported that the acetabular implant when opening during surgery had metal particles and a ripped bag sealing the implant.The surgery was completed with another device.No known consequence or impact to the patient.

• Brand Name: G7 PPS LTD ACET SHELL 62H
• Common Device Name: PROSTHESIS, HIPS
• 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: 22204868
• Report Number: 0001825034-2025-01723
• Device Sequence Number: 15382168
• Product Code: PBI
• UDI-Device Identifier: 00880304524279
• UDI-Public: (01)00880304524279(17)280912(10)6361099
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/13/2025

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 010000668
• Device Lot Number: 6361099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2025
• 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: 05/30/2025
• Initial Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2018
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown