MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRILOGY LONGEVITY XLPE 0 DEG POLY LINER 56X36; PROSTHESIS, HIP

Catalog Number	00630505636
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994); Joint Dislocation (2374)
Date of Event	06/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial hip procedure.The patient experienced dislocation approximately one-month post-implantation while twisting to the right and left.The patient underwent a closed reduction at the emergency department and was also given a brace.The patient noted feeling unstable while lying flat.Subsequently, the patient was revised approximately 2 weeks later due to recurrent dislocations and pain.During the procedure, a hematoma was evacuated.The shell, head, and neck were exchanged without complications.The stem remained implanted.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: cat# 00877503602 lot# 3214350 biolox⮠delta, ceramic femoral head, m, 㸠36/0, taper 12/14.Cat# 00620205622 lot# 67050519 shell porous with cluster holes 56 mm.Cat# 00625006520 lot# 66481242 bone scr 6.5x20 self-tap.Cat# 00625006530 lot# j7728757 bone scr 6.5x30 self-tap.Cat# 00784803400 lot# 64553739 modular neck j 12/14 neck taper use with +0 heads only.Cat# 00771300700 lot# 66793621 modular femoral stem press-fit plasma sprayed cementless size 7.5.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: d5; g3; h2; h3; 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.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient had a initial tha.Office notes suggests patient had pain and numbness on the operative site.Patient states they had a hip dislocation while twisting right to left.A brace was provided to the patient.X-rays were taken and found implants were well fixed and well aligned.The patient had a revision due to dislocation and continued pain.A hematoma was evacuated.Acetabular components were well fixed but revised to a dual mobility which provided stability needed with the neck and head exchange.No other complication noted.A definitive root cause cannot be determined.Based on the medical records, the 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.

• Brand Name: TRILOGY LONGEVITY XLPE 0 DEG POLY LINER 56X36
• 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: 22337826
• Report Number: 0001822565-2025-02158
• Device Sequence Number: 9069829
• Product Code: LPH
• UDI-Device Identifier: 00889024666634
• UDI-Public: (01)00889024666634(17)290823(10)66890239
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K002960
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2025

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: 00630505636
• Device Lot Number: 66890239
• 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: 06/02/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 89 KG