MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VIVACIT-E DM BEARING 28X46MM; PROSTHESIS, HIP

Catalog Number	110031013
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign: germany.The device will not be returned for analysis as the product remains implanted.An investigation of the reported event is in progress.Once the investigation is completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent an initial hip procedure during which an incorrectly sized liner was implanted as the packaging label did not correspond to the packaged product.No known impact or consequence to the patient has been reported, and no additional treatment or revision has taken place.The patient remains under monitoring.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 updated: b4; b5; g3; h2; h3; h6; h7; h9; h11.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.The reported event could not be confirmed.Device history record was reviewed and a commingle that occurred during manufacturing was later identified.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: no complications, adverse events, or indication of any implant mismatch or further concerns identified within the initial op note provided.Left total hip arthroplasty with good stability and leg length achieved.Postop images show proper implant position with correct articulation investigation results concluded that the reported event is attributed a manufacturing deficiency.Multiple bearings did not measure to the size listed on the implant packaging as the affected lots are manufactured in the same facility at the same time.Corrective action has been initiated as a result of this event.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 for trends.
Event or Problem Description
No further event information at time of this report.

• Brand Name: VIVACIT-E DM BEARING 28X46MM
• 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: 23451014
• Report Number: 0001822565-2025-03951
• Device Sequence Number: 8074194
• Product Code: LPH
• UDI-Device Identifier: 00889024572713
• UDI-Public: (01)00889024572713(17)300406(10)67160480
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K190656
• 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
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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: 110031013
• Device Lot Number: 67160480
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 03/10/2026
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 97765
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male