MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CONTINUUM TRABECULAR METAL; PROSTHESIS, HIP

Catalog Number	00875705801
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Pain (1994); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Ankylosis (4527); Joint Impingement (4834)
Date of Event	01/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately nine months post-implantation, the patient underwent a right hip revision due to the cup position being retroverted.The patient experienced pain and instability.Pain, antalgic gain, forced external rotation in flexion, difficulty doing straight leg raise, impingement, and ho were all observed during planning for the revision.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: cat# 300049080 lot# 3064025 ms-30, stem.Cat# 0100358010 lot# 65015320 ms-30, distal centralizer.Cat# 802203602 lot# 2995138 femoral head 12/14.Cat# 00801102016 lot# 64264382 allen medullary cement plug.Cat# 00885101336 lot# 65015320 36mm i.D.Size ll neutral liner.Cat# 00625006535 lot# j6915988 bone screw self-tapping.G2: foreign - event occurred in australia.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
No further information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d4; g3; h2; h3; h4; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.Letters were provided and reviewed by a health care professional.Review of the available records identified the following: confirms revision planned for pain, antalgic gait, forced external rotation in flexion, difficulty doing straight leg raise, impingement and ho."no history of instability but the small components of his presentation all contribute to the unsatisfactory outcome." x-ray: ho, brooker 2-3.Ct: no loosening.Mri: impingement of iliopsoas muscle.Ops: retroversion of cup 8°, anteversion of stem 28°.Aspiration: no signs of sepsis, esr 29, crp 11.Images assessed and not sent for review for documentation provides sufficient findings.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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: CONTINUUM TRABECULAR METAL
• 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: 24379495
• Report Number: 0001822565-2026-00541
• Device Sequence Number: 13334451
• Product Code: JDI
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2026

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: 00875705801
• Device Lot Number: 63523377
• 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: 01/27/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2016
• 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: Required Intervention; Hospitalization
• Patient Sex: Male