MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VIVACIT-E DM BEARING 28X44MM; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in united kingdom the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the hospital was contacted to inform them of the recall.It was subsequently identified that the affected implant had already been implanted into a patient.It was reported that no revision surgery is scheduled as the patient is unfit for surgery and experiencing post operative complications not relating to the procedure.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, h2, h3, h6.The following section was corrected: d5.The reported event was unable to be confirmed, as no product or pictures were provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.It was later identified a commingle occurred during manufacturing.The root cause of the reported issue is attributed to a manufacturing deficiency.Multiple complaints were identified that involved a 46mm bearing and a 44mm bearing that did not measure to the size listed on the box they were packaged in.They are related due to the fact that both lots are manufactured at the same facility, of the same part family, and manufactured at the same time.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 additional information to report.

• Brand Name: VIVACIT-E DM BEARING 28X44MM
• 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: 23508770
• Report Number: 0001822565-2025-04034
• Device Sequence Number: 21258821
• Product Code: LPH
• UDI-Device Identifier: 00889024572706
• UDI-Public: (01)00889024572706(17)300406(10)67160447
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K942479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2025

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 Model Number: N/A
• Device Catalogue Number: 110031012
• Device Lot Number: 67160447
• 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: 10/16/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2025
• 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