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

Catalog Number	30103604
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a hair on the implant.A new liner as opened.There was no known impact or consequences to the patient.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).The customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected} updated: d5; g3; h2; h3; h4; h6 no product was returned; visual evaluation of the provided photo found the packaging was previously opened.A hair-like fiber was identified on the device.As the packaging was previously opened, the source of the debris cannot be confirmed.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause or condition of the device when it left zimmer biomet cannot be determined, as the product was previously opened.This complaint cannot 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.

• Brand Name: G7 VIVACIT-E 36MM I.D. SIZE D NEUTRAL LINER
• Common Device Name: PROSTHESIS, HIP
• 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: 21864610
• Report Number: 0001822565-2025-01051
• Device Sequence Number: 20793916
• Product Code: LPH
• UDI-Device Identifier: 00889024519893
• UDI-Public: (01)00889024519893(17)300105(10)67099068
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K190660
• 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): 08/12/2025

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: Health Professional
• Device Catalogue Number: 30103604
• Device Lot Number: 67099068
• 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: 04/07/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2025
• 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