MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 FREEDOM VIVACIT-E LINER CONSTRAINED NEUTRAL 36 MM I.D. SIZE D; PROSTHESIS, HIP

Catalog Number	30203604
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) the 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.
Event or Problem Description
It was reported that during the surgery, the surgeon was seating the liner when the ring popped off.There were no known impact or consequences to the patient.Another device was used to complete the procedure.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected} updated: d4; g3; h2; h3; h4; h6 visual examination of the returned product identified the device was returned unassembled, the ring is off the liner and the plug is no longer in the liner.There are scratches on both sides and around the freedom ring.There are indentations and scratches around the ¿p¿ o.D.Where the ring sits on the liner and on the ¿n¿ o.D.Just above where the ring sits.There are indentations and scratches also present on the top flat surface, outer locking barb, o.D.Spherical surface, scallops, and i.D.Of the liner.The plug has nicks and scratches present around it.Diameter measurements taken for the liner and ring were conforming to specification.No other damage was noted during visual evaluation.Review of the device history record identified no deviations or anomalies during manufacturing.Medical records were not provided.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
No further information at the time of this report.

• Brand Name: G7 FREEDOM VIVACIT-E LINER CONSTRAINED NEUTRAL 36 MM I.D. SIZE D
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• 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: 23166924
• Report Number: 0001822565-2025-03582
• Device Sequence Number: 12972984
• Product Code: PBI
• UDI-Device Identifier: 00889024588394
• UDI-Public: (01)00889024588394(17)291204(10)66843080
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2026

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 Catalogue Number: 30203604
• Device Lot Number: 66843080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2025
• 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: 09/02/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 09/29/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2024
• 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: Female
• Patient Weight: 57 KG