MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER CONSTRAINED +5 MM OFFSET 36 MM; PROSTHESIS, HIPS

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	03/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D1: liner constrained +5 mm offset 36 mm i.D.Size g for use with g7 acetabular system only.D10: 30203607 liner constrained neutral 36 mm i.D.Size g for use with g7 acetabular system only 66829224.G2: foreign: canada.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 the surgeon tried to impact 2 different freedom liners into g7 osseoti shell and the liners would not engage and lock in.Spent 20+ minutes clearing and making sure there was nothing causing the hang up and do not know why the liners would not engage.Eventually the +5-liner locked in.No known impact or consequence to the patient.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4;d4;g3;h2;h3;h;h6;h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.Medical records were not provided.A definitive root cause cannot be determined.This complaint could not be confirmed.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: LINER CONSTRAINED +5 MM OFFSET 36 MM
• Common Device Name: PROSTHESIS, HIPS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21775602
• Report Number: 0001822565-2025-00899
• Device Sequence Number: 8199896
• Product Code: PBI
• UDI-Device Identifier: 00889024588608
• UDI-Public: (01)00889024588608(17)281101(10)66246573
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K212512
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2025

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: 30253607
• Device Lot Number: 66246573
• 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: 03/13/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Patient Sex: Unknown