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

Catalog Number	110031009
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Aseptic loosening (4883)
Date of Event	07/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: unk screws; cat: p0463044, lot: 0001825836, avan cmntd shell ss 44mm.G2: foreign ¿ australia.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 five months post-implantation, the patient underwent a hip revision due to a dislocation of bearing and cup and inferior screws loose in the bone.Three screws were removed and replaced.A larger head with more offset was placed.Attempts have been made and no further information has been provided.
Event or Problem Description
It was reported that approximately five months post-implantation, the patient underwent a hip revision due to a dislocation of bearing and cup and inferior screws loose in the bone.Three screws were removed.Screw holes were cemented and longer screws put in and locked to cage.The cemented liner was too stuck and could not be removed.A larger head with more offset was placed.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: b5; g3; h2; h3; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: ct images show a dislocated right total hip arthroplasty with a custom acetabular implant in place.A definitive root cause cannot be determined.This complaint can be confirmed via the x-ray evaluation.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: DUAL MOBILITY
• 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: 22529420
• Report Number: 0001822565-2025-02568
• Device Sequence Number: 20816341
• Product Code: LPH
• UDI-Device Identifier: 00889024572676
• UDI-Public: (01)00889024572676(17)290219(10)66508726
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K190656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted 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): 07/31/2025

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: 110031009
• Device Lot Number: 66508726
• 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: 07/03/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female