MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LONGEVITY; PROSTHESIS, HIP

Catalog Number	110030997
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374); Ambulation or Postural Difficulties (2544)
Date of Event	01/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat: 163663 lot: j7317140 28mm dia cocr mod hd +3mm nk.Cat: unk lot: 107290 unk sell.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.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 approximately four months post-implantation, the patient underwent a hip closed reduction attempt and then revision due to a dislocation of the head and liner, disassociation of the liner and shell, pain, and a mild to moderate antalgic gait.Head and liner were exchanged.Shell and stem retained.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: d4; g3; g4; h2; h3; h4; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Medical records were provided.Review of the available records identified the following: revision op notes - presented to the office with pain and unusual noise coming from the hip, found to have dissociation of the poly component of the dm head ball a definitive root cause cannot be determined.Complaint is 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 information is available at the time of this report.

• Brand Name: LONGEVITY
• 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: 23014766
• Report Number: 0001822565-2025-03355
• Device Sequence Number: 9539287
• Product Code: LPH
• UDI-Device Identifier: 00889024572553
• UDI-Public: (01)00889024572553(17)281203(10)66406245
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K190656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 110030997
• Device Lot Number: 66406245
• 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: 08/18/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic